FDA - News

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Successful Audits in API Manufacturing Begin and End with Ongoing Quality Processes

Tags: API Manufacturing | Audits | Blog | CDMO | FDA

Posted August 31, 2021
What Has Changed in Method Development and Validation for Pharmaceuticals and Why You Need to Know

Tags: Analytical Methods | API Manufacturing | Blog | DMFs | FDA | Research and Development

Posted April 8, 2021
Incomplete Documentation Can Make or Break Projects in API Manufacturing

Tags: Blog | cGMP | FDA | Quality Systems

Posted November 16, 2020
Setting Unprecedented Records in Vaccine Development During the Pandemic

Tags: API Manufacturing | Blog | covid | FDA

Posted June 30, 2020
What Sponsors Should Know About DMF Filings

Tags: Blog | DMFs | FDA | GDUFA

Posted June 8, 2020
Why the Educated Sponsor is Our Best API Customer

Tags: API Manufacturing | CDMO | Compliance | FDA

Posted May 26, 2020
Avoiding FDA Drug Rescissions: Sponsors Seek CDMOs With Strong Regulatory Track Records

Tags: API Manufacturing | Blog | FDA | GDUFA

Posted February 24, 2020
BPTF Testifies Before House Committee on Energy & Commerce About the Pharmaceutical Supply Chain

Tags: Congress | FDA | GDUFA | Generic Drug Manufacturing | Press Releases

Posted October 30, 2019
Safeguarding Pharmaceutical Supply Chains in a Global Economy

Tags: Congress | FDA | Video

Posted October 29, 2019
Who’s Manufacturing Your Prized API?

Tags: Audit | Blog | CDMO | cGMP | FDA

Posted September 30, 2019