FDA Denies Vanda Petition on Generics of Schizophrenia Drug Fanapt December 8, 2016 The FDA disagreed with the company’s argument that its exclusivity protected the deletion of claims. Read More
EMA Lays Out First Steps in Implementing ISO Standards for Drug Identifiers December 8, 2016 The EMA released details on two of the four SPOR data sets. Read More
FDA Finalizes Guidance on Clinical Pharmacology Product Labeling December 8, 2016 The clinical pharmacology section must contain at least three subsections. Read More
Former FDA Official Strikes Settlement with SEC Over Insider-Trading December 7, 2016 Gordon Johnston will pay $108,000 to resolve the allegations. Read More
FDA Publishes Draft Guidance for Submitting Pharmacokinetic Modeling Analyses December 7, 2016 The agency recommended organizing the study report into five sections. Read More
Senate Poised To Approve 21st Century Cures Act December 6, 2016 The U.S. Senate is moving toward approving the 21st Century Cures Act with a vote expected this afternoon. Read More
FDA Hands Warning Letter to STI Pharma for Deficiencies in Reporting Adverse Events December 6, 2016 The company did not properly evaluate several of the ADEs it received. Read More
FDA Strikes Certain Data Requirements for Imported Products in Final Rule December 6, 2016 The volume of FDA-regulated imports entering the country rose from 6 million to 35 million. Read More
New Drugs Director John Jenkins to Retire from FDA in January December 5, 2016 John Jenkins, director of CDER’s Office of New Drugs, plans to retire Jan. 6, 2017, after nearly 25 years of service to the FDA. Read More
India Singles Out 200 Drugmakers As ‘High Risk’ For Defying Compliance Standards December 5, 2016 CDSCO joined forced with state drug regulators to conduct the inspections of the manufacturing and testing facilities. Read More
Discontinued Formulation of Protonix IV Is Unsafe for Generics, FDA Says December 5, 2016 FDA chemists observed a presence of solid and liquid particles above acceptable limits. Read More
EMA Finds Efficacy, Safety Concerns Hinder Approvals for CNS Therapies December 5, 2016 There were 103 applications submitted for CNS candidates from 1995 to 2014 that showed effectiveness and safety issues. Read More