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With the Prescription Drug User Fee Act set to expire in September 2017, the FDA will kick into full gear on reauthorization negotiations this June, FDA Acting Commissioner Stephen Ostroff said Monday. Read More
The FDA is taking the unusual step of pressing Genervon Biopharmaceuticals to release all data from a Phase IIa trial of its amyotrophic lateral sclerosis drug, including an analysis of changes in patients’ lung function. Read More
An Indian pharmacists group is urging the government to immediately require detailed instructions on storage temperatures on all drug labels, to prevent improper handling in the supply chain and by end users. Read More
Bristol-Myers Squibb has cut short the comparative arm of a trial of its immunotherapy drug Opdivo after interim results showed a clear benefit over chemotherapy. Read More
A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in a Wednesday citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More