Public Policy

Recent Posts

DEA Releases Final Rule on Disposal of Controlled Substances
Posted on 2 Dec 2014 by Duane Morris LLP

The U.S. Drug Enforcement Administration (DEA) has released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010 (the "Disposal... Read More

Physician's Failure To Read Trumps Drug Company's Failure To Warn
Posted on 2 Dec 2013 by William A. Ruskin

When the prescribing physician in a pharmaceutical product liability case admits that at her deposition that she never reviewed the manufacturer’s label before treating her patient and that the label played no role in her decision to prescribe the... Read More

U.S. House Introduces Bill on Federal Oversight of Compounding Pharmacies
Posted on 7 Oct 2013 by Duane Morris LLP

On September 12, 2013, U.S. Representative Morgan Griffith (R-Va.) introduced H.R. 3089 ("the House Bill") [ enhanced version available to lexis.com subscribers ], which proposes a structure for federal oversight of compounding pharmacies. The... Read More

FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
Posted on 1 Jul 2014 by Duane Morris LLP

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers , which provides answers to questions from public comments received on the... Read More

FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees
Posted on 22 Apr 2014 by Duane Morris LLP

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which... Read More