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Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Loper Bright v. Raimondo

U.S. Supreme Court overrules Chevron and restores courts’ obligation to exercise independent judgment - On June 28, 2024, in one of the last decisions of the Term, the U.S. Supreme Court issued its long-awaited decision in...more

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more

Department of Justice Vows Vigorous Enforcement of Clinical Trial Fraud

As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more

President Trump Signs FDA User Fee Reauthorization Bill into Law – A Relief for the Medical Device Industry

On August 18, 2017, in the nick of time, President Trump signed the FDA User Fee Reauthorization Bill of 2017 (FDARA) (H.R. 2430) into law, bringing a sigh of relief from both FDA and Industry. The law reauthorizes the...more

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