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Manufacturers Pharmaceutical Industry Center for Drug Evaluation and Research (CDER)

Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Sheppard Mullin Richter & Hampton LLP

FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management...more

Hogan Lovells

FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience - Long-Awaited ICH Q13 draft...

Hogan Lovells on

Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more

Sheppard Mullin Richter & Hampton LLP

Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week....more

Hogan Lovells

The FDA now offers cGMP Declarations

Hogan Lovells on

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

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