RAPS

FDA reprimands two firms for missing validation programs, poor facility maintenance

Inadequate validation of manufacturing processes, failure to conduct microbiological testing of drugs and keeping a facility in a poor state of repair, prompted the US Food and Drug Administration ...
RAPS

FDA warns drug, device makers for CGMP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug and device manufacturers for failing to meet its current good manufacturing practices (CGMP). Among the violations, ...
Business Wire

Tivic Health Enters GMP Manufacturing Validation Agreement with Scorpius BioManufacturing in Preparation for FDA Submission

FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...
JD Supra

Navigating FDA Risks in Life Sciences M&A: A Practical Diligence Guide

Counsel advising acquirers in pharmaceutical, biotechnology, and medical device transactions must assess a target's compliance with Food and ...
Forbes

Why Validation In Life Sciences Can No Longer Be A One-Time Event

Dr. Siva Samy is the founder and CEO of ValGenesis, an inventor with 8 patents in digital and AI-based validation, and a Ph.D in Pharma. For decades, validation in life sciences has been treated as a ...