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Regulatory Oversight › Data Integrity

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

Rothwell, Figg, Ernst & Manbeck, P.C. on

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Carlton Fields

On Cybersecurity, Grab the Low-Hanging Fruit

Carlton Fields on

SEC Tells Firms to Stop Missing the Basics on Cybersecurity - The SEC’s Office of Compliance Inspections and Examinations (OCIE) reported in a recent Risk Alert that many investment advisers and broker-dealers are failing to...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Hogan Lovells

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Hogan Lovells on

Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

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