483 Roundup: Devicemakers Cited for Complaints, Quality
The FDA hit Grind Guard Technologies with a Form 483 for failing to review all complaints, faulty procedures for suppliers and quality audit deficiencies. Source: The GMP Letter
IMDRF Roundup: Updates From Russia, Brazil, Australia and Asia
The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai. Source: The GMP Letter
SynCardia Systems Nailed for MDR Deficiencies
The FDA issued a warning letter to SynCardia Systems over issues regarding medical device reporting at its Tucson, Arizona facility. Source: The GMP Letter
EMA Issues Q&A on Exposure Limits And Prevention of Cross-Contamination
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Source: Drug GMP Report
FDA Ad Enforcement Targets Risk Information, Pre-Approval Promotions
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to…
Florida Drugmaker Draws FDA Warning for Repackaging
The FDA warned Phase 4 Pharmaceutical for repackaging deficiencies and the lack of procedures for drug distribution at its Aventura, Florida facility. Source: Drug GMP Report
Continuous Manufacturing Bill Would Pair Universities With FDA, Industry
Rep. Frank Pallone (D-N.J.) proposed new legislation on continuous manufacturing during a joint visit with FDA Commissioner Scott Gottlieb to Rutgers University to discuss the campus’ role in advancing the…
Wyden Turns Up Heat on Novartis in Cohen Controversy
In the latest development in the Michael Cohen-Novartis scandal, the U.S. Senate Committee on Finance pressured Novartis CEO Vasant Narasimhan for contracts and communications made between the pharma company and…
AIDS Nonprofit Loses Patent Appeal Against Gilead
A federal appeals court affirmed the dismissal of a lawsuit brought by the nonprofit AIDS Healthcare Foundation (AHF) challenging Gilead’s patents on several of its HIV drugs. Source: Drug Industry…
FDA Proposes to Drop Second Appeals for Medical Product Classifications
A process for second appeals of FDA designations for medical product classifications would be eliminated under a new FDA proposed rule. Source: Drug Industry Daily
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