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Biosimilar sponsors need to include the name of the reference product in labeling if the label includes clinical data derived from that product, the FDA said in a final guidance released Wednesday. Read More
FDA Commissioner Scott Gottlieb announced the release of a new action plan for biosimilars on Wednesday and said it would help prime the “anemic” biosimilar market. Read More
The senator asked if Pfizer will make the deferrals permanent if the White House’s drug pricing blueprint does not take effect during this calendar year. Read More
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previously been available for nonprescription drugs, Commissioner Scott Gottlieb said on Tuesday in announcing a new draft guidance on the initiative.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