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August 23, 2017
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
August 21, 2017
A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.
The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
August 18, 2017
The agency published guidance on identifying trading partners under DSCSA.
FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
August 14, 2017
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
August 10, 2017
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
August 08, 2017
The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.
August 04, 2017
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.