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FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

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

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

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

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

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

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

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

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

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

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

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

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

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...

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

Assessing Protections for Biomaterials Suppliers 12 Years After the Biomaterials Access Assurance Act

The growth of the biomaterials market, which analysts expect to reach $58.1 billion by 2014, shows that biomaterials suppliers have flourished by relying on the Biomaterials Access Assurance Act of 1998 (BAAA), 21 U.S.C. §§...more

California Issues New Green Chemistry Requirements for Consumer Products

In a highly anticipated new development, California’s Department of Toxic Substances Control (“DTSC”) submitted its Green Chemistry Proposed Regulation for Safer Consumer Products to the state Office of Administrative Law...more

FDA to Increase Criminal Prosecution of Corporate Officials in the Pharmaceutical Industry

In a recently released letter to U.S. Sen. Chuck Grassley (R-Iowa), the Government Accountability Office (GAO) reported the results of its study into the Food and Drug Administration's (FDA) criminal investigation of...more

Client Alert: FDA Issues Order Requiring Safety and Effectiveness Information from Older Medical Devices

On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the...more

Wyeth v. Levine: No Federal Preemption for Drug Labeling

The Supreme Court yesterday decided Wyeth v. Levine, the long-awaited decision on preemption of state court product liability claims against the pharmaceutical manufacturers. In a 6 to 3 decision, the Supreme Court determined...more

Greening of Consumer Products - May 14, 2008

IN THIS ISSUE: *New bills push for better regulations on toxic products sold in California *Connecticut moves to limit lead in children's toys *Climate Counts' second annual company scorecard finds food services industry...more

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