Final Order Puts Computerized Cognitive Aids in Class II December 28, 2016 These were the first devices the FDA indicated for cognitive testing after a brain injury. Read More
Twenty Democratic Senators Offer to Work with Trump to Lower Drug Prices December 28, 2016 They urged Donald Trump to support legislation to restrict large price increases. Read More
Complaint Evaluation Procedures Net Circle Prime Form 483 December 23, 2016 Records of acceptable suppliers, contractors and consultants were not being adequately established. Read More
UK’s Antitrust Authority: Actavis Inflated Prices of Hydrocortisone Generics by 12,000% December 23, 2016 Actavis inflated the price of 10 mg and 20 mg hydrocortisone tablets. Read More
Poor Supplier Evaluations Lead To Form 483 for CME America December 22, 2016 Potential suppliers were not evaluated and selected based on their ability to meet specified requirements. Read More
EMA to Pilot Program for Advice on Biosimilar Development December 22, 2016 Applicants seeking advice must submit a briefing package to the EMA. Read More
FDA, CMS Parallel Review Program To Be Made Permanent December 21, 2016 The agencies learned two primary lessons from the pilot program. Read More
Japan to Share GMP Inspection Findings on API Makers With EU, FDA, TGA December 21, 2016 The drug regulators conduct their inspections in compliance with GMP standards laid out in the ICH guideline Q7. Read More
Foundation Medicine Garners FDA Approval for Companion Device for Rubraca December 20, 2016 The device is a tissue-based, genomic assay. Read More
ABPI Rebukes Five Drugmakers for Breaching Code of Practice December 20, 2016 AstraZeneca infringed four clauses of the code in promoting COPD therapy. Read More
Circulatory Technology Hit With Form 483 for Improper Reporting, Evaluations December 19, 2016 The company failed to submit an MDR report within 30 days of becoming aware of a device that had malfunctioned. Read More
GMP Violations Earn U.S. Drug Manufacturer FDA Warning Letter December 19, 2016 The company released drug products to customers without conducting final tests. Read More