OR WAIT null SECS
July 12, 2017
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.
July 11, 2017
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
July 10, 2017
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
July 05, 2017
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
June 29, 2017
The agency determined additional guidance was needed to reduce regulatory compliance burden.
June 27, 2017
The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.
June 21, 2017
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
June 15, 2017
Congressional measures lack the support to move forward.