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Medical Devices › 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

Epstein Becker & Green

Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents

Epstein Becker & Green on

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking.  What do the data show regarding FDA’s performance in moving...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Hogan Lovells

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

Hogan Lovells on

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some...more

Akin Gump Strauss Hauer & Feld LLP

FDA Implements a New “Concept of Operations” for Drug Inspections

Akin Gump Strauss Hauer & Feld LLP on

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

Hogan Lovells

FDA Enforcement Activities Update for FY 2016: CDRH Warning Letters Fall to 8-Year Low

Hogan Lovells on

The Food and Drug Administration (FDA) recently released statitistics regarding its enforcement actvities for FY 2016. Of note, the number of warning letters issued by the Center for Devices and Radiological Health (CDRH),...more

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