Suitability Petition (SP)
|
|
|
- Teresa Robyn Bell
- 6 years ago
- Views:
Transcription
1 Suitability Petitions Dr. Ken Harshman, Director Division of Generic Animal Drugs Center for Veterinary Medicine AAVPT Workshop Veterinary Drug Regulatory Life Cycle (A to Z) March 2, 2011 Suitability Petition (SP) A suitability petition is a means for a person to request FDA approval to be able to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from a reference listed new animal drug (RLNAD). Approved SP = permission to seek approval of the proposed generic drug with the requested change Provided for under the Federal Food, Drug, and Cosmetic Act, section 512(n)(3) Suitability Petition What & Where? A type of citizen petition submitted in compliance with 21 CFR requesting FDA to approve or disapprove a specific change The request and FDA s response are publicly disclosed Submitted to Division of Dockets Management* *Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD
2 Suitability Petition Why? Provides a means for innovation with generic new animal drugs within specific defined limits SP is a request to submit an ANADA for a proposed generic new animal drug that is not identical to a RLNAD SP must be approved prior to submitting an ANADA Suitability Petition When? Permissible changes Change in route of administration; Change in dosage form; Change in strength (concentration); or Change in one of the active ingredients in a combination new animal drug; (same pharmaceutical class) OR Change in one of the Type A medicated articles in a feed use combination new animal drug. More than one change can be requested at one time. Suitability Petition How? Petition must contain information to show: Identification of the proposed generic product and a description of the permissible change(s) being requested; Identification of the RLNAD, including dosage form; strength, & active ingredient(s); and Comprehensive statement of grounds (justification) for the proposed change from the RLNAD being requested. 2
3 Suitability Petition How? Draft labeling for the generic new animal drug that is the subject of this petition and currently approved labeling for the RLNAD. Request for a categorical exclusion from the requirement to prepare an environmental assessment. Certification that this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. FDA will approve or disapprove a suitability petition no later than 90 days after the date such petition is submitted. FDA will approve a suitability petition unless: Investigations must be conducted to show the safety or effectiveness of the proposed generic new animal drug because of the proposed permissible change(s); or Investigations must be conducted to show the safety for human consumption of any residues in food because of the proposed permissible change(s); or FDA has determined that the RLNAD has been discontinued from sale for safety or effectiveness reasons; or RLNAD has been voluntarily withdrawn from sale and the agency not yet determined whether the withdrawal is for safety or effectiveness reasons; or 3
4 The petition seeks to change an active ingredient in a proposed generic new animal drug that contains a single active ingredient; or The petition seeks to change more than one active ingredient in a proposed combination generic new animal drug; or Any of the proposed changes from the RLNAD would necessitate significant labeling changes and jeopardize the safe or effective use of the product. Suitability Petition Sponsor Action Post SP approval action: Call to discuss next steps in project development plan Begin drug approval process Open a generic investigational new animal drug (JINAD) file Submit an ANADA Post SP approval action: FDA may, at any time during the course of its review of an ANADA, request additional information to evaluate the change approved in the petition. FDA may withdraw approval of a suitability petition if FDA receives any information demonstrating that the petition no longer satisfies the conditions under which FDA approved it. 4
5 Suitability Petition Common Problems Failure to contact CVM prior to submitting the SP Not required To determine whether the RLNAD is appropriate To ensure all components of the petition are included Failure to provide adequate justification for the proposed change(s) Suitability Petition Additional References CVM Policy Letter No. 2: Format and content for suitability petitions 203/03n-0324b-sup Tab-16-vol2.pdf Opens to a blank page; scroll down to reference 21 CFR : Petition to request a change from a listed drug. Contact Information Dr. Ken Harshman, Director Division of Generic Animal Drugs john.harshman@fda.hhs.gov 5
Communicating with CVM
Communicating with CVM Diane L. Heinz, DVM, MBA Director, Policy and Regulations Staff Center for Veterinary Medicine, FDA CVM s s Website Information related to recalls, including pet food How to file
HOGAN & HARTSON APR -9 P4 :18 BY HAND DELIVERY
HOGAN & HARTSON 2741 10 APR -9 P4 :18 Hogan & Hartson up Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 +1.202.637.5600 Tel +1.202.637.5910 Fax www.hhlaw.com Philip Katz Partner 202.637.5632
Guidance for Industry
Guidance for Industry Citizen Petitions and Petitions for Stay ofaction Subject to Section 505(q) ofthe Federal Food, Drug, and Cosmetic Act DRAFT GUIDANCE This guidance document is being distributed for
Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Overthe-Counter
This document is scheduled to be published in the Federal Register on 05/23/2018 and available online at https://federalregister.gov/d/2018-10993, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products;
This document is scheduled to be published in the Federal Register on 03/02/2018 and available online at https://federalregister.gov/d/2018-04281, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act
This document is scheduled to be published in the Federal Register on 01/07/2015 and available online at http://federalregister.gov/a/2015-00002, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
PHARMACEUTICAL LAW GROUP PC
in L PHARMACEUTICAL LAW GROUP PC AT THE INTERSECTION OF FDA REGULATION AND INTELLECTUAL PROPERTY 900 SEVENTH STREET, NW - SUITE 650 - WASHINGTON, DC 20001-3886 T 202 589 1780 F 202 318 2198 WWW.PHARMALAWGRP.COM
Food and Drug Administration Modernization Act of 1997: Modifications to the List of
This document is scheduled to be published in the Federal Register on 02/11/2015 and available online at http://federalregister.gov/a/2015-02801, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Proposal to Refuse to Approve a New Drug Application for Oxycodone Hydrochloride
This document is scheduled to be published in the Federal Register on 02/13/2018 and available online at https://federalregister.gov/d/2018-02903, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products;
This document is scheduled to be published in the Federal Register on 01/07/2016 and available online at http://federalregister.gov/a/2016-00066, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the
This document is scheduled to be published in the Federal Register on 01/13/2016 and available online at http://federalregister.gov/a/2016-00529, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Laser Products--Conformance with IEC Ed. 3 and IEC Ed. 3.1 (Laser
This document is scheduled to be published in the Federal Register on 01/19/2018 and available online at https://federalregister.gov/d/2018-00898, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
NOV PROPOSAL TO DEBAR NOTICE OF OPPORTUNITY FOR HEARING Docket No. OON-1530
DEPARTMENT OF HEALTH 81 HUhbiN SERVICES Public Health Service CERTIFIED MAIL RETURN RECEIPT REQUESTED Richard L. Borison, M.D. EF401347 Hancock State Prison P. 0. Box 339 Sparta, GA 3 1087 NOV 2 6 2002
Determination of Regulatory Review Period for Purposes of Patent Extension; XIENCE
This document is scheduled to be published in the Federal Register on 04/29/2015 and available online at http://federalregister.gov/a/2015-09902, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Review of Existing General Regulatory and Information Collection Requirements of the
This document is scheduled to be published in the Federal Register on 09/08/2017 and available online at https://federalregister.gov/d/2017-19047, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
o 1205 Culbreth Dr., Suite 200, Wilmington, NC Phone : Facsimile :
Osmotica Pharmaceutical 1?54,Lt. 27 P2 :05 BY HAND DELIVERY Division of Dockets Management Food and Drug Administration Department of Health and Human Services 563"0 Fishers Lane, Room 1061 Rockville,
United States. Country QUESTIONNAIRE
Annex to C. SCIT 2505 Country United States QUESTIONNAIRE ON THE GRANT AND PUBLICATION OF SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL AND PHYTOPHARMACEUTICAL PRODUCTS OR EQUIVALENT INDUSTRIAL PROPERTY
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its regulations
This document is scheduled to be published in the Federal Register on 07/25/2013 and available online at http://federalregister.gov/a/2013-17752, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
Clarification of When Products Made or Derived from Tobacco Are Regulated as Drugs,
This document is scheduled to be published in the Federal Register on 01/16/2018 and available online at https://federalregister.gov/d/2018-00555, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of
This document is scheduled to be published in the Federal Register on 11/08/2016 and available online at https://federalregister.gov/d/2016-26912, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A
Reprinted from FDA s website by Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA. ) ) ) ) ) ) ) ) ) ) ) Plaintiffs, ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Defendants.
Case 1:16-cv-01350 Document 1 Filed 06/28/16 Page 1 of 19 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA LANNETT COMPANY, INC., 13200 Townsend Road, Philadelphia, PA 19154 and LANNETT
Guidance for the public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings
Reprinted from FDA s website by Guidance for the public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings FINAL GUIDANCE Comments and suggestions
FDA REFORM LEGISLATION Its Effect on Animal Drugs TABLE OF CONTENTS
November 12, 1997 FDA REFORM LEGISLATION Its Effect on Animal Drugs TABLE OF CONTENTS I. BACKGROUND II. REFORM PROVISIONS AFFECTING ANIMAL DRUGS A. Supplemental Applications - Sec. 403 B. Manufacturing
Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industry and Review Staff
Formal Dispute Resolution: Appeals Above the Division Level Guidance for Industry and Review Staff Good Review Practice DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.
Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and
This document is scheduled to be published in the Federal Register on 06/15/2018 and available online at https://federalregister.gov/d/2018-12825, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
The Consumer Healthcare Products Association (CHPA) submits these. comments on the proposal published by the Food and Drug Administration (FDA) in 64
February 28, 2000 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: FDA Proposal to Revise the Citizen Petition Regulation, 64 Fed. Reg.
=======================================================================
[Federal Register: June 26, 2001 (Volume 66, Number 123)] [Rules and Regulations] [Page 33829-33830] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26jn01-2] =======================================================================
Indirect Food Additives: Adhesives and Components of Coatings. SUMMARY: The Food and Drug Administration (FDA or we) is amending the food additive
This document is scheduled to be published in the Federal Register on 07/12/2013 and available online at http://federalregister.gov/a/2013-16684, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
Lupin Pharmaceutkals,Inc.
Lupin Pharmaceutkals,Inc. 1011 1 9 A 8 : 43 VIA FEDERAL EXPRESS Division of Documents Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville,
Citation to Code of Federal Regulations and statutory citation (as applicable):
January 26, 2018 Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Docket No.: FDA-2017-N-5101
Criteria Used to Order Administrative Detention of Food for Human or Animal
This document is scheduled to be published in the Federal Register on 02/05/2013 and available online at http://federalregister.gov/a/2013-02497, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of
This document is scheduled to be published in the Federal Register on 03/04/2016 and available online at http://federalregister.gov/a/2016-04700, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
SUMMARY: The Food and Drug Administration (FDA or we) is reinstating the provision
This document is scheduled to be published in the Federal Register on 04/01/2019 and available online at https://federalregister.gov/d/2019-06238, and on govinfo.gov 4164-01-P DEPARTMENT OF HEALTH AND
This responds to your citizen petition dated July 24, 2009, submitted on behalf of Osmotica
~ 1: 'i;ßrvices. ú" L /t" DEPARTMENT OF HEALTH & HUMAN SERVICES ;i ~ :; E "'1\ ~.lqlf,n:a Food and Drug Administration Rockville MD 20857 Mark S. Aikman, Phar.D. Vice President, Regulatory Affairs and
Litigation Webinar Series. Hatch-Waxman 101. Chad Shear Principal, San Diego
Litigation Webinar Series Hatch-Waxman 101 Chad Shear Principal, San Diego 1 Overview Hatch-Waxman Series Housekeeping CLE Contact: Jane Lundberg lundberg@fr.com Questions January 25, 2018 INSIGHTS Litigation
(4- I. Background. Douald O. Beers Arnold & Porter LLP 555 Twelfth Street, N.W. Washington, D.c
(4- DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 Douald O. Beers Arnold & Porter LLP 555 Twelfth Street, N.W. Washington, D.c. 20004-1206
We have carefully considered the Petition.! For the reasons described below, the Petition is granted.
DEPARTMENT OF HEALTH &. HUMAN SERVICES... -------------_._- Food and Drug Administration Rockville MD 20857 JUN 17 2010. Pankaj Dave, Ph.D. Vice President, Regulatory Affairs Navinta LLC 1499 Lower Ferry
Internal Agency Review of Decisions; Requests for Supervisory Review of Certain. Decisions Made by the Center for Devices and Radiological Health
This document is scheduled to be published in the Federal Register on 01/17/2018 and available online at https://federalregister.gov/d/2018-00646, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
Case 1:12-cv RBW Document 9 Filed 12/03/12 Page 1 of 6 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
Case 1:12-cv-01936-RBW Document 9 Filed 12/03/12 Page 1 of 6 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ENDO PHARMACEUTICALS INC., Plaintiff, v. Civil Action 12-1936 (RBW UNITED STATES FOOD
Teva Pharmaceuticals USA Attention: Scott Tomsky Vice President, U.S. Generics Regulatory Affairs 425 Privet Road Horsham, PA 19044
DEPARTMENT OF HEALTH & HUMAN SERVICES ANDA 091028 Food and Drug Administration Silver Spring, MD 20993 Teva Pharmaceuticals USA Attention: Scott Tomsky Vice President, U.S. Generics Regulatory Affairs
WASHINGTON LEGAL FOUNDATION
Docket No. FDA-2017-N-5101 COMMENTS of WASHINGTON LEGAL FOUNDATION to the FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH & HUMAN SERVICES Concerning Review of Existing Center for Drug Evaluation and
Iff/]) FEB Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC
![Iff/]) FEB Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC](/thumbs/90/102180811.jpg "Iff/]) FEB Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC")
DEPARTMENT OF HEALTH &. HUMAN SERVICES FEB 2 2 2011 Food and Drug Administration Rockville MD 20857 Gregory 1. Glover Pharmaceutical Law Group PC 900 Seventh Street, NW Suite 650 Washington, DC 20001-3886
Subpart A General Provisions PART 7 ENFORCEMENT POLICY. 21 CFR Ch. I ( Edition)
Pt. 7 21 CFR Ch. I (4 1 06 Edition) Southwest Import District Office: 4040 North Central Expressway, suite 300, Dallas, TX 75204. PACIFIC REGION Regional Field Office: 1301 Clay St., suite 1180 N, Oakland,
Case 1:07-cv RMU Document 71-2 Filed 05/08/2007 Page 1 of 6. ANDA , Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg.
Case 1:07-cv-00579-RMU Document 71-2 Filed 05/08/2007 Page 1 of 6 DEPARTMENT OF HEALTH & HUMAN SERVICES ANDA 76-719, Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg. SENT BY FACSIMILE AND U.S. MAIL
Early Resolution Mechanism for Patent Disputes Regarding Approved Drug Products - Canada
Early Resolution Mechanism for Patent Disputes Regarding Approved Drug Products - Canada Pharma Workshop 4 AIPPI Toronto September 16, 2014 Warren Sprigings Direct Dial: +1-416-777-2273 warren@sprigings.com
CMDv/BPG/012. BEST PRACTICE GUIDE for Informed consent for MRP and DCP procedures. Edition number: 00. Edition date: 14 June 2013
EMA/CMDv/377880/2010 BEST PRACTICE GUIDE for Informed consent for MRP and DCP procedures Edition number: 00 Edition date: 14 June 2013 Implementation date: 1 September 2013 Page 2 of 10 TABLE OF CONTENTS
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for Permit as a nresident Prescription Drug Manufacturer Virtual Form.: DBPR-DDC-236
2013 PA Super 215. Appellants No. 83 EDA 2012
2013 PA Super 215 IN RE: REGLAN/METOCLOPRAMIDE LITIGATION, IN THE SUPERIOR COURT OF PENNSYLVANIA APPEAL OF: MORTON GROVE PHARMACEUTICALS INC., AND WOCKHARDT USA, LLC, Appellants No. 83 EDA 2012 Appeal
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for Permit as a nresident Prescription Drug Manufacturer Form.: DBPR-DDC-202 APPLICATION
2018 Dairy Policy: the Good, the Bad and the Ugly. Mary Knigge Dairy Farmers of America Vice President, Government Relations
2018 Dairy Policy: the Good, the Bad and the Ugly Mary Knigge Dairy Farmers of America Vice President, Government Relations Family farm in Omro, Wis. Displaced by robotic milkers in 2000 National Milk
Case 5:13-cv SMH-MLH Document 1 Filed 06/20/13 Page 1 of 11 PageID #: 1
Case 5:13-cv-01983-SMH-MLH Document 1 Filed 06/20/13 Page 1 of 11 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF LOUISIANA SHREVEPORT DIVISION UNITED STATES OF AMERICA v. Plaintiff,
Article 1 General principles and objectives
NOTE: The EU reserves the right to make subsequent modifications to this text and to complement it at a later stage, by modifying, supplementing or withdrawing all, or any part, at any time. The relationship
A. ANDAs and Eligibility for 180-day Exclusivity
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD 20857 SENT VIA ELECTRONIC MAIL Dear Celecoxib ANDA Applicant: This letter addresses the legal and regulatory scheme governing
21 CFR Part 50 - Protection of Human Subjects
21 CFR Part 50 - Protection of Human Subjects Subpart A General Provisions 50.1 Scope. 50.3 Definitions. Subpart B Informed Consent of Human Subjects 50.20 General requirements for informed consent. 50.21
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for Permit as a Prescription Drug Manufacturer Virtual Form.: DBPR-DDC-235 APPLICATION
federal register Department of Health and Human Services Part III Wednesday December 3, 1997 Food and Drug Administration
federal register Wednesday December 3, 1997 Part III Department of Health and Human Services Food and Drug Administration Final Guidance on Industry-Supported Scientific and Educational Activities; Notice
Subpart A General Provisions
Pt. 11 necessitated such an action within 24 hours or sooner if requested by the Deputy Commissioner. In the absence or unavailability of the Deputy Commissioner, the presiding officer shall notify the
HP0557, LD 821, item 2, 124th Maine State Legislature, Amendment C "A", Filing Number H-625, Sponsored by
PLEASE NOTE: Legislative Information cannot perform research, provide legal advice, or interpret Maine law. For legal assistance, please contact a qualified attorney. Amend the bill by striking out everything
WASHINGTON LEGAL FOUNDATION
Docket No. FDA-2016-D-2021 COMMENTS of WASHINGTON LEGAL FOUNDATION to the FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH & HUMAN SERVICES Concerning DRAFT GUIDANCE FOR INDUSTRY AND FDA STAFF: DECIDING
FDA-2010-N-0371 FDA-2010-D-0354
October 12, 2010 Dr. Margaret A. Hamburg, Commissioner Department of Health and Human Services Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket Nos. FDA-2010-D-0370
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics
State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for Permit as a Prescription Drug Manufacturer Form.: DBPR-DDC-201 APPLICATION
PART 7 ENFORCEMENT POLICY
Food and Drug Administration, HHS Pt. 7 District Office, San Francisco, CA Laboratory Branch. District Office, Los Angeles, CA. Domestic Import Operations Branch. District Office, Seattle, WA. Pacific
Florida Senate SB 518 By Senator Saunders
By Senator Saunders 1 A bill to be entitled 2 An act relating to controlled substances; 3 creating s. 831.311, F.S.; prohibiting the 4 sale, manufacture, alteration, delivery, 5 uttering, or possession
T H E W O R L D J O U R N A L O N J U R I S T I C P O L I T Y. BOLAR EXEMPTION VS. DATA EXCLUSIVITY: RIGHT TO HEALTH vs RIGHT OF PATENT HOLDER
BOLAR EXEMPTION VS. DATA EXCLUSIVITY: RIGHT TO HEALTH vs RIGHT OF PATENT HOLDER Rhea Roy Mammen M.S. Ramaiah College of Law, Bangalore Introduction Pharmaceutical Patent has seen an increasing conflict
No ORAL ARGUMENT HELD JUNE 1, 2015 UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
Case: 14-72794, 06/30/2015, ID: 9594168, DktEntry: 20, Page 1 of 6 No. 14-72794 ORAL ARGUMENT HELD JUNE 1, 2015 UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT IN RE PESTICIDE ACTION NETWORK NORTH
Terms of Reference and Rules of Procedure of the Management Committee
Terms of Reference and Rules of Procedure of the Management Committee MGT-P0008-6 7 SEPTEMBER 2018 CONTENTS 1 ESTABLISHMENT 3 2 MANDATE 3 3 COMPOSITION 4 4 MEETINGS 4 5 MINUTES OF MEETINGS 4 6 URGENT DECISIONS
Reproduced by Sabinet Online in terms of Government Printer s Copyright Authority No dated 02 February 1998 STAATSKOERANT, 22 JULIE 2011
STAATSKOERANT, 22 JULIE 2011 No.34463 17 No. R. 587 22 July 2011 MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO. 101 OF 1965) GENERAL REGULATIONS MADE IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES
REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 concerning the export and import of hazardous chemicals
L 201/60 Official Journal of the European Union 27.7.2012 REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 concerning the export and import of hazardous chemicals
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule that adopts,
This document is scheduled to be published in the Federal Register on 05/30/2013 and available online at http://federalregister.gov/a/2013-12833, and on FDsys.gov OF20123 4160-01-P DEPARTMENT OF HEALTH
Notice. Re: Draft Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales
June 30, 2016 Notice Our file number: 16-107491-541 Re: Draft Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales Health Canada is pleased
Case 1:16-cv Document 1 Filed 06/06/16 Page 1 of 9
Case 1:16-cv-01052 Document 1 Filed 06/06/16 Page 1 of 9 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA THE GOOD FOOD INSTITUTE, 1380 Monroe St. NW, #229 Washington, DC 20010, Plaintiff, v.
Patent Term Extensions in Taiwan
This article was published in the Markgraf Ergänzende Schutzzertifikate - Patent Term Extensions on 2015. Patent Term Extensions in Taiwan I. Introduction Ruth Fang, Lee and Li Attorneys at Law The patent
Subpart K Administrative Detention of Food for Human or Animal Consumption. Food and Drug Administration, HHS 1.379
Food and Drug Administration, HHS 1.379 (c) The failure of any person to make records or other information available to FDA as required by section 414 or 704(a) of the Federal Food, Drug, and Cosmetic
Request for Notification from Industry Organizations Interested in Participating in the
4160-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Request for Notification from Industry Organizations Interested in Participating in the Selection
FILED: NEW YORK COUNTY CLERK 09/08/ :43 AM INDEX NO /2014 NYSCEF DOC. NO. 1 RECEIVED NYSCEF: 09/08/2014
FILED NEW YORK COUNTY CLERK 09/08/2014 0943 AM INDEX NO. 158728/2014 NYSCEF DOC. NO. 1 RECEIVED NYSCEF 09/08/2014 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK --------------------------------------------------------x
PDA STANDARDS DEVELOPMENT PROGRAM Policies and Procedures
PDA STANDARDS DEVELOPMENT PROGRAM Policies and Procedures Approved by the PDA Executive Management July 15, 2016 Approved by the ANSI Executive Standards Council March 01, 2017 Parenteral Drug Association
FREEDOM OF INFORMATION ACT AND THE FDA
Freedom of Information Act and the FDA / 1 FDA Tobacco Project FREEDOM OF INFORMATION ACT AND THE FDA In June 2009, President Obama signed the Family Smoking and Tobacco Control Act 1 into law, authorizing
United States Court of Appeals for the Federal Circuit
United States Court of Appeals for the Federal Circuit 2009-1368 WYETH HOLDINGS CORPORATION and WYETH (now known as Wyeth LLC), v. Plaintiffs-Appellants, Kathleen Sebelius, SECRETARY OF HEALTH AND HUMAN
I'D [3, 2 7 ~ ~ a Anthony Figg Lisa N. Phillips
4 j ROTHWELL, FIGG, ERNST & MANBECK, P.c. 1425 K Street, N.W. G. Franklin Rothwell Anne M. Sterba Suite 800 6045 7 I'D [3, 2 7 ~ ~ a Anthony Figg Lisa N. Phillips Washington, D.C. 20005 : i-_. f~ ~azbara
Recommendation for Mutual Recognition Procedure after finalisation of an article 34 referral procedure with a positive decision by the EC
13 October 2011 EMA/CMDv/422851/2009 Recommendation for Mutual Recognition Procedure after finalisation of an article 34 referral procedure with a positive decision by the EC 1. Introduction Community
INTERIM GUIDANCE DOCUMENT Therapeutic Products Programme
Health Canada Santé Canada INTERIM GUIDANCE DOCUMENT Therapeutic Products Programme CONTENTS 1. PURPOSE OR OBJECTIVE 2. BACKGROUND 3. SCOPE 4. INTERPRETATION 5. RESPONSIBILITIES AND PROCEDURES Exemption
21 C.F.R DEFINITIONS
SECTION-BY-SECTION REDLINE OF FDA S FINAL REGULATIONS ON ANDAS AND 505(b)(2) APPLICATIONS TO IMPLEMENT TITLE XI OF THE MMA 21 C.F.R. 314.3 DEFINITIONS (a) The definitions and interpretations contained
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL FOR AGRICULTURE AND RURAL DEVELOPMENT
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL FOR AGRICULTURE AND RURAL DEVELOPMENT Brussels, 1 February 2018 Rev1 NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED
NUCLEAR REGULATORY COMMISSION. [Docket Nos and ; NRC ]
![NUCLEAR REGULATORY COMMISSION. [Docket Nos and ; NRC ]](/thumbs/86/94737435.jpg "NUCLEAR REGULATORY COMMISSION. [Docket Nos and ; NRC ]")
This document is scheduled to be published in the Federal Register on 08/09/2013 and available online at http://federalregister.gov/a/2013-19309, and on FDsys.gov [7590-01-P] NUCLEAR REGULATORY COMMISSION
Concurrent Session III March 6, Investigating Allegations of Scientific Misconduct and the False Claims Act
Concurrent Session III March 6, 2003 3.05 Investigating Allegations of Scientific Misconduct and the False Claims Act Edwin Rauzi Davis Wright Tremaine Seattle, WA U.S. Department of Health and Human Services
Bender's Health Care Law Monthly September 1, 2011
Bender's Health Care Law Monthly September 1, 2011 SECTION: Vol. 2011; No. 9 Federal Pre-Emption Under The Food, Drug & Cosmetic Act From Medtronic, Inc. V. Lohr; Pliva, Inc. V. Mensing By Frederick R.
EXTENDING THE LIFE OF A PATENT IN THE UNITED STATES
EXTENDING THE LIFE OF A PATENT IN THE UNITED STATES by Frank J. West and B. Allison Hoppert The patent laws of the United States allow for the grant of patent term extensions for delays related to the
A. Bayer's New Drug Application for Precose
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD 20857 William A. Rakoczy, Esq. Rakoczy, Molino, Mazzochi & Siwik, LLP 6 West Hubbard St. Suite 500 Chicago, IL 60610 Dear
Preemption in Nonprescription Drug Cases
drug and medical device Over the Counter and Under the Radar By James F. Rogers, Julie A. Flaming and Jane T. Davis Preemption in Nonprescription Drug Cases Although it must be considered on a case-by-case
SOP Informed Consent: Process, Documentation, and Waivers
Office of Research Integrity - Human Subjects SOP #: ORI(HS)- 6.01 1.0 Page #: Page 1 of 6 Approved By: ORI Executive Director *Signature on file Date: Date First Effective: 11/18/2013 Approved by: Biomedical
D2 a copy of a Commission Decision of 22 January 2009 for a new oral formulation of COZAAR suitable for paediatric use.
Decision in Respect of an Application by E.I. Du Pont De Nemours & Company for the Grant of an Extension of Duration of the SPC No. 1996/028 for COZAAR 1. This decision relates to an application by E.I.
QUESTION & ANSWER (Q&A) ON SPECIFIC PROVISIONS OF THE ASEAN COSMETIC DIRECTIVE (ACD)
Association of South East Asian Nations (ASEAN) QUESTION & ANSWER (Q&A) ON SPECIFIC PROVISIONS OF THE ASEAN COSMETIC DIRECTIVE (ACD) FINAL VERSION 1 of 6 Released Final Version 1.0 DOCUMENT INFORMATION
CMDv/BPG/018. BEST PRACTICE GUIDE for Worksharing. Edition number: 03. Edition date: 16 May Implementation date: 01 January 2010
EMA/CMDv/75429/2009 BEST PRACTICE GUIDE for Worksharing Edition number: 03 Edition date: 16 May 2013 Implementation date: 01 January 2010 CMDv Secretariat: 7 Westferry Circus, Canary Wharf, London, E14
Subtitle F Medical Device Innovations
130 STAT. 1121 (B) unless specifically stated, have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.. (b) CONFORMING AMENDMENTS.
Case 1:17-cv UNA Document 1 Filed 12/22/17 Page 1 of 10 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
Case 1:17-cv-01844-UNA Document 1 Filed 12/22/17 Page 1 of 10 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE AMGEN INC., v. Plaintiff, TORRENT PHARMACEUTICALS LTD. and TORRENT
Segal McCambridge Singer & Mahoney, Ltd Market Street, Suite 2600 Philadelphia, PA (215) Fax: (215) : : : : : : : : : :
Theodore C. Flowers, Esquire tflowers@smsm.com Attorney Identification No. 82218 Segal McCambridge Singer & Mahoney, Ltd. 1818 Market Street, Suite 2600 Philadelphia, PA 19103 (215) 972-8015 Fax (215)
The Patented Medicines (Notice of Compliance) Regulations: What patents are eligible to be listed on the register?
The Patented Medicines (Notice of Compliance) Regulations: What patents are eligible to be listed on the register? Edward Hore Hazzard & Hore 141 Adelaide Street West, Suite 1002 Toronto, ON M5H 3L5 (416)
Case 1:10-cv JCJ Document 20 Filed 04/14/10 Page 1 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
Case 110-cv-00137-JCJ Document 20 Filed 04/14/10 Page 1 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MILLENNIUM PHARMACEUTICALS, INC. and SCHERING CORP., Plaintiffs, CIVIL ACTION
Regulatory Update: Food Safety and Nutrition
Regulatory Update: Food Safety and Nutrition Ricardo Carvajal Hyman, Phelps & McNamara, P.C. www.hpm.com www.fdalawblog.net North American Millers Association March 2015 Today s Agenda Ø FSMA Update Ø