FDA also chastised the company for its failure to conduct stability testing program for its drug products in a timely manner. FDA said that “stability testing was overdue by 3 months or longer for a ...

The US Congressional Budget Office (CBO) says a permanent cut to the National Institutes of Health (NIH) budget and extending drug review times at the Food and Drug Administration (FDA) would likely ...

340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 RAPS Announcements | 21 July 2025 | RAPS ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, the ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Senators reveal how much Lilly, Pfizer paid telehealth companies (STAT) FDA advisers vote against ...

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is ...

Most pivotal clinical trials supporting the accelerated approval of nononcology products reported surrogate measures as primary endpoints, according to a recent research letter published in JAMA.

Come mingle with your regulatory colleagues and friends in the relaxed atmosphere of Sugarhouse Park. A main entrée will be provided by the chapter. Bring your favorite side dish or dessert to share.

PDG said selection of the Korean Pharmacopoeia was a consensus decision that @reflects the quality of the Korean Pharmacopoeia@s application and its alignment with the PDG@s mission to promote global ...

The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...

To reduce the risk of aluminum toxicity in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...

The US Food and Drug Administration (FDA) has published recent warning letters to a fertility clinic for not properly screening donors for sexually transmitted infections (STI), a drug compounder and ...