Early PSMF quality shapes inspection focus, and deficiencies are commonly interpreted as system-level governance gaps ...

AI-enabled QC shifts assurance from retrospective release testing to real-time control, leveraging anomaly detection, root-cause acceleration, and virtual witnessing across labs, manufacturing, and ...

The FDA has launched a programme to make it easier for drug companies to set up manufacturing facilities in the US and reduce the country's reliance on imported medicines. Today, the regulator ...

GSK's antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, has hit the mark in two phase 3 trials and will be filed for approval as a potential first-in-class treatment for the disease.

It’s been 31 years since one of the darkest days in Oklahoma and American history as the bombing of the Alfred P. Murrah ...

A Winnipeg organization is urging people to get their drugs tested after it says five people connected to its community died after using substances within the last two weeks.

A375, HEK293T, Sk-Mel-3 and Sk-Mel-24 cell lines were obtained from the American Type Culture Collection. A375 and HEK293T cells were maintained in ...

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The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing (NGS) methods in nonclinical studies to assess the safety risks associated ...

The Best Business Cloud Storage and File-Sharing Providers for 2026 Storing and syncing files in the cloud makes your life easier and keeps your data safer. The best cloud storage services we've ...