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 ...

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.

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 ...

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 ...

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 ...

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.