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The FDA has issued final guidance clarifying its thought process for evaluating bulk drug substances that are being considered for the 503B bulks list, which specifies substances that outsourcing facilities may use in drug compounding. Read More
When food adversely affects a drug’s safety or efficacy, requiring fasted dosing, the sponsor should conduct studies to determine a realistic time interval between drug dosing and meals, the guidance states. Read More
According to the U.S. Attorney for the Eastern District of Pennsylvania, Lehigh received a waiver for its oxycodone hydrochloride NDA but then went on to secure two more waivers for NDAs relating to potassium chloride for oral solution. Read More
A federal judge ruled Teva can’t challenge the FDA’s new policy on generic exclusivity because the drugmaker has not proved a danger of imminent injury. Read More
The U.S. Court of Appeals for the Third Circuit upheld a Delaware federal district court’s decision to throw out an FTC lawsuit that sought to curb alleged misuse of citizen petitions to delay market entry of generic drugs. Read More
FDA Commissioner Scott Gottlieb on Wednesday made his agency’s case before a key House appropriations subcommittee as the lawmakers begin the process of developing next year’s budget. Read More
Commissioner Scott Gottlieb said the agency’s aim in the guidance is to “promote innovation in NRT by outlining a broader set of criteria that can serve as the basis for new approvals.” Read More