The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

A U.S. representative is pressing the FDA for information about ByHeart Inc., the company linked to an outbreak of infant botulism poisonings. In a letter to FDA Administrator Marty Makary, Rep. Rosa ...

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...

Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week ...

In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...

The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional assessments at manufacturing and other lower-risk facilities.

QT Imaging Holdings, Inc. (Nasdaq: QTI) (“QT Imaging” or the “Company”), a medical device company engaged in the research, development, and ...

The US Food and Drug Administration (FDA) recently warned two drug makers and a drug testing lab for current good manufacturing practices (CGMP) violations, such as marketing products after detecting ...

Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Compliance & Enforcement Team examines a new FDA compliance program for Center for Drug Evaluation and Research (CDER)-regulated biologics, highlighting the ...

Lengthy timelines and high costs remain major challenges in pharmaceutical R&D. As pressure grows to bring medicines to patients faster, laboratories must find smarter ways to accelerate their ...

A federal pullback could shift oversight responsibilities to the states, with consumer groups expressing concern that the move will slow responses to outbreaks. Stacey Leasca is an award-winning ...