Drug Labeling

More Information on Drug Labeling

• Press Statement: FDA Rule Withdrawal Fails to Modernize Generic Labeling and Endangers Patient Safety, December 13, 2018
• Comments on the FDA’s Draft Guidance on Updating Generic Drug Labeling After The Marketing Application For The Reference Listed Drug Has Been Withdrawn, September 9, 2016
• Press Statement: FDA Delay in Safety Rule Leaves Patients Nationwide at Risk, December 3, 2015
• Additional comments on the FDA’s proposed generic drug labeling rule and an industry alternative, April 27, 2015
• Comments on the FDA’s proposed rule to allow generic drug manufacturers to update product labeling with newly discovered risk information, March 13, 2014
• Statement: FDA Action Benefits Industry, Perpetuates Unsafe Use of Opioid Pain Medications, September 11, 2013
• Statement: FDA Proposal to Revise Drug Labeling Regulations Is Welcome News, Will Improve Drug Safety, July 3, 2013
• Generic Drug Labeling: A Report on Serious Warnings Added to Approved Drugs and on Generic Drugs Marketed Without a Brand-Name Equivalent, June 20, 2013
• Petition Regarding Generic Drug Labeling, August 29, 2011
• Wyeth v. Levine (Does FDA approval of drug labels preempt state-law damages claims?), March 4, 2009
• Comments on FDA Proposal on Labeling Requirements for Lactation Drugs, August 27, 2008
• Letter on the Ability of Drug Companies to Add Safety Warnings to Their Products’ Labels, March 17, 2008
• Testimony on CDER’s Risk Communication Failures, December 7, 2005
• Comments on the FDA Implementation of the Data Quality Act, June 13, 2002
• Article in JAMA: Timing of New Black Box Warnings and Withdrawals for Prescription Medications, May 1, 2002
• Comments on the Proposed Revision to Prescription Drug Label Format, June 22, 2001