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…
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. Source: Drug Industry Daily
Baxter subsidiary Claris Injectables was hit with a warning letter for significant water damage, falsely recording data and neglecting to properly investigate out-of-specification results at its Ahmedabad, Gujarat facility. Source:…
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.…
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…
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…
The FDA cited Q A Laboratories after a lengthy inspection of its of Kansas City, Missouri facility revealed serious sanitation deficiencies and other nonconformances. Source: Drug Industry Daily
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. Source: Drug Industry Daily
The FDA cited Pfizer’s Hospira manufacturing facility in Sriperumbudur, Tamil Nadu for a slew of repeat deficiencies, including falsifying data, in a Form 483 flagged as Official Action Indicated –…
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. Source: Drug Industry Daily