Drug Approval Process

More Information on the Drug Approval Process

• Letter to Congress Regarding Legislation to Reauthorize PDUFA and MDUFA, April 25, 2022
• Comments Submitted to the FDA Regarding the Reauthorization of the Prescription Drug User Fee Act, October 28, 2021
• Presentation at the FDA’s Public Meeting on the Recommendations for Prescription Drug User Fee Act (PDUFA) Reauthorization, September 28, 2021
• Presentation at the FDA’s Public Meeting on the Reauthorization of PDUFA, July 23, 2020
• Comments on the FDA’s Proposal to Change the Approval Package Documentation Posted on the Agency’s Website For New Drugs and Biologics, August 26, 2019
• Comments on the FDA’s Draft Guidance on the Assessment of Pressor Effects of Drugs, July 30, 2018
• Comments on FDA Transparency, July 20, 2010
• Testimony Encouraging Greater FDA Transparency, June 24, 2009
• Testimony on Behind-the-Counter Availability of Certain Drugs, November 14, 2007
• Petition to Require that Certain Advisory Committee Meetings Include an FDA Staff Presentation, June 21, 2007
• Congressional Testimony on Development of Pediatric Therapies, May 22, 2007
• Letter Regarding Prescription Drug User Fee Act, May 4, 2007
• Comments on FDA Proposal on Access to and Charging for Investigational Drugs, March 19, 2007
• Letter in the Lancet: Suboptimum Use of FDA Drug Advisory Committees, December 23, 2006
• Regulatory Affairs Journal Article: The U.S. FDA at at Crossroads, July 2006
• Statement on the 100th Anniversary of the FDA, June 27, 2006
• Article in Law and Contemporary Problems: Access to Pharmaceutical Data at the FDA, Summer 2006
• Testimony on Possible Switch of Orlistat (Xenical) to OTC Status, January 23, 2006
• Letter Supporting the Strengthening of the Open Public Hearing as Part of FDA Advisory Committee Meetings, June 15, 2005
• Testimony on Public Health Dangers of Prescription-to-OTC Switch of Lovastatin (Mevacor), January 14, 2005
• Testimony on CDER’s Risk Communication Failures, December 7, 2005
• Letter Questioning the Actions of a Senior NIH Scientist and Former AstraZeneca Consultant, July 8, 2004
• Public Citizen v. FDA (Seeking records on an unapproved use of a drug), February 26, 2004
• Comments on the FDA Implementation of the Data Quality Act, June 13, 2002
• Testimony on the Risk Management of Prescription Drugs, May 22, 2002
• Testimony on FDA Risk-Management Concept Papers, April 3, 2003
• Comments on the Disclosure of Conflicts of Interest for Participants in FDA Advisory Committees, March 5, 2002
• Comments on the Prescription Drug User Fee Act (PDUFA), January 25, 2002
• Comments Concerning Disclosure of Information on Investigational Products, April 18, 2001
• Comments on FDA Proposed Changes to Disclosure of Information from FDA Advisory Committee Meetings, March 26, 2001
• Testimony on Prescription Drug User Fee Act (PDUFA), September 15, 2000
• Testimony on Problems with Prescription-to-OTC Switch of Cholesterol-Lowering Drugs, July 13, 2000
• Testimony on Switching Drugs from Prescription to OTC, June 28, 2000
• Study of the Drug Industry’s Performance in Finishing Required Postmarketing Research (Phase IV) Studies, April 13, 2000
• FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals, December 2, 1998
• Public Citizen v. FDA (Seeking records on discontinued drugs), January 5, 1994