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Fees for pharmacy benefit managers should no longer be calculated based on a medicine’s list price, the nation’s largest drug manufacturers’ association says in new comments filed with federal regulators. Read More
The U.S. House of Representatives passed the Over-the-Counter Monograph Safety, Innovation and Reform Act, a bill that would reform the OTC monograph system by using a user fee system to expedite FDA review of OTC monographs and encourage innovation. Read More
The FDA proposes to extend the new drug application pathway to include therapeutic indications that have not previously been available for nonprescription drugs, Commissioner Scott Gottlieb said on Tuesday in announcing a new draft guidance on the initiative. Read More
The European Medicines Agency issued the first report on its open access policy for clinical data submitted by sponsors in their marketing applications for new drugs. Read More
A federal court issued a preliminary injunction against Dr. Reddy’s generics for Indivior’s addiction treatment Suboxone (buprenorphine and naloxone) pending the outcome of a patent challenge. Read More