Manufacturers, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

New FDA Guidance on AI and Medical Products

Troutman Pepper on 4/12/2024

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

FDA’s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report

Gardner Law on 2/23/2024

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more

Act II: The Senate Unveils Its Draft

King & Spalding on 6/2/2022

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

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

Sheppard Mullin Richter & Hampton LLP on 5/20/2022

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

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

Hogan Lovells on 8/24/2021

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

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

Sheppard Mullin Richter & Hampton LLP on 5/21/2019

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

The FDA now offers cGMP Declarations

Hogan Lovells on 10/15/2018

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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