Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

Glenmark Pharmaceuticals receives FDA warning letter for Indore facility, commits to resolving compliance issues promptly.

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging ...

Master FDA expectations and best practices. Learn about facility design, personnel qualification, and contamination control, tackling FDA scrutiny and aligning with EU Annex 1 & ICH Q9/Q10 principles.

The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA ...

Biotech deals involving assets developed in China are surging, a Jefferies report shows. | Biotech deals involving assets ...

The FDA has issued warning letters to United King Foods Private Limited in Pakistan and Mother Earth Minerals, Inc. in Ogden, UT, for significant violations of federal food safety regulations.

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...

The FDA typically does not make complete response letters public, citing confidentiality, putting the onus on the drug companies to share that information, which they often do selectively.

The goal is to improve public understanding of the FDA decision-making process. (HealthDay News) — The U.S. Food and Drug Administration has published more than 200 complete response letters, or ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. The attempt may have created more questions, however, with only ...