Science, Computers & Technology, Products Liability, Administrative Law

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

by James A. Hoover | Burr & Forman on 12/6/2012

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more

Intermediates Compliance Warning

by K&L Gates LLP on 10/26/2012

ECHA raised serious concerns recently about the quality and compliance of 574 companies' registration dossiers, all of which relate to intermediate substances. The companies have been notified via REACH-IT and given 3 months...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

Confounding Issues about Compounding Pharmacy Regulation

by Mintz Levin - Health Law on 10/18/2012

Originally published in the American Health Lawyers Association, Washington, D.C. on October 17th, 2012 New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing...more

Product Liability Update -- July 2012

by Foley Hoag LLP on 7/27/2012

In This Issue: *First Circuit Affirms Judgment Against Generic Drug Manufacturer on Plaintiff’s Design Defect Claim, Holding: (i) Product May Be Found “Defective” on Proof It Is “Unreasonably Dangerous”; (ii) Design...more

Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

by Morgan Lewis on 4/3/2012

State and federal courts reject efforts to categorize salmonella as a "communicable disease." While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more

Governor Brown Signs Two Bills Intended to Protect Children From Toxic Exposures

by Sheppard Mullin Richter & Hampton LLP on 10/17/2011

In an effort to protect children (and, to a lesser extent, adults) from toxic exposure, California has banned the use of the controversial chemical Bisphenol A (BPA) in baby bottles and sippy cups, and has eliminated certain...more

FDA Releases New Strategic Plan for Regulatory Science

by Dechert LLP on 8/24/2011

This week the FDA released a plan for fostering innovative science. It is entitled the “Strategic Plan for Regulatory Science,” and it focuses on the agency’s goal to enhance the processes for developing and evaluating new...more

FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

by Morgan Lewis on 8/10/2011

On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more

Supreme Court Issues Opinion in Important Securities Fraud Case Concerning Pharmaceutical Manufacturers’ Obligations to Disclose...

by King & Spalding on 3/24/2011

On March 22, 2011, the U.S. Supreme Court issued its opinion in Matrixx Initiatives, Inc. v. Siracusano, 562 U.S. ___ (2011), an important securities fraud class action with potential implications for pharmaceutical and...more