Amanda Murphy, Senior Director at GlobalData, discusses how real-time intelligence can turns regulatory events into ...

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency ...

Solara Active Pharma Sciences Limited is pleased to announce that its multi-product manufacturing facility at Mangalore, ...

Sandeep Rao, MD & CEO said "We have successfully completed the FDA inspection at our Mangalore facility between 25th to 29th ...

The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records issues at the manufacturing ...

Lupin has announced that the United States Food and Drug Administration's inspection of its Nagpur facility has come to a ...

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...

Danger, device maker! Counting to 15 is a lot tougher than you think Device makers are by now quite aware that FDA-inspected firms have 15 working days to respond to an inspectional form 483, but is ...

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for ...

In addition to safety questions about its COVID-19 vaccine, Johnson & Johnson (J&J) is facing manufacturing challenges as a key partner, Emergent Biosolutions Inc., has yet to get FDA approval to ...

Lies, shredded documents and a trashcan dowsed in acid: Intas Pharmaceuticals’ new write-up from the FDA is a textbook example of what not to do when investigators come knocking. It also offers a ...