FDA Proposes Certain Device Accessories Be Defined As Class I
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed…
FDA to Allow Combo Products to Submit Malfunction Summary Reports
The FDA is allowing manufacturers of combination products to submit certain device malfunction medical device reports on a quarterly basis. Source: The GMP Letter
DITTA Urges FDA to Fix MDSAP Inconsistencies
The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and…
FDA Cites Indian Manufacturer for Training, Record Deficiencies
The FDA hit Indian injectable drugmaker Auronext Pharma over violations found during a February inspection of the company’s Bhiwadi, Rajasthan facility. Source: Drug Industry Daily
PhRMA Targets Hospitals’ Role in Hiking Drug Costs
PhRMA released a new report Wednesday highlighting the role of U.S. hospitals in increasing drug costs, showing they mark up prices for patients by an average of nearly 500 percent.…
FDA Issues New Manual for Prioritizing Site Inspections
The FDA Wednesday released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections. Source: Drug Industry Daily
FDA Releases Final Guidance on Drugs for Hay Fever, Non-Allergic Rhinitis
The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final…
FDA Hits Malaysian OTC Manufacturer for Multiple Deficiencies
Malaysian OTC drug manufacturer AmLion Toothpaste drew a 483 for numerous quality violations including inadequate cleaning procedures. Source: Drug Industry Daily
FDA May Hit Record for Generic Approvals
The FDA is on track to top its fiscal year 2017 record for generic approvals despite receiving fewer ANDA submissions, according to the agency’s latest generic drug activities report. Source:…
FDA Issues Final Guidance on Physiologically-Based Pharmacokinetic Analyses
The FDA released final guidance Tuesday for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on…
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