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The FDA is now directing sponsors to international guideline recommendations for the durations of general toxicity studies that evaluate the direct dosing of drug metabolites. Read More
The European Medicines Agency broadened the scope of its first-in-human trials guidelines, accounting for advancements in clinical trials protocols and complex dose-escalation studies. Read More
The U.S. Supreme Court has refused to hear a case on whether biosimilar makers must wait six months after receiving FDA approval to bring a product to market. Read More
Manufacturers of investigational new drugs intended for research, teaching or chemical analysis do not have to register their establishments with the FDA, according to a revised final rule on the electronic registration of foreign and domestic facilities. Read More
The FDA rejected Vanda Pharmaceuticals petition to delay the approval of ANDAs referencing its schizophrenia therapy Fanapt until its three-year market exclusivity for a new indication expires. Read More
The FDA will not approve generics referring to the original and discontinued formulation of Protonix IV, after a review of scientific data confirmed that therapy for gastroesophageal reflux disease was pulled off the market for safety reasons. Read More
Generics sponsors hoping to submit the ICH’s alternative postmarket report, known as the the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said. Read More
The FDA has made several amendments to the requirements for filing citizen petitions and petitions for stay of action when used to delay ANDA applications. Read More
Allergan, along with Ironwood Pharmaceuticals, filed a suit against five generics companies, alleging infringement of nine patents covering its irritable bowel syndrome drug, Linzess. Read More
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017. Read More