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The FDA released guidelines for developing drugs for prophylaxis of inhalational anthrax, saying applications will be reviewed through the Animal Rule pathway due to safety and ethical concerns about human trials. Read More
In an alert that cited both safety and efficacy concerns, the FDA said it would pull over-the-counter oral benzocaine products from the market unless manufacturers discontinue their sale as teething products. Read More
Citing efficacy and other concerns, a joint FDA advisory committee voted 18-1 not to recommend approval of Insys’ buprenorphine spray for acute pain. Read More
The report suggests establishing arrangements that permit data sharing and improved communications among applicants, registry holders, marketing authorization holders and regulators. Read More
The FDA will allow over-the-counter marketing of certain sunscreen products without an approved application provided they avoid certain labeling claims and otherwise comply with all OTC requirements, the agency said in a final guidance. Read More
FDA Commissioner Scott Gottlieb discussed the FDA’s plans to roll out more guidances on cell and gene therapies this year in a Tuesday speech to the Alliance for Regenerative Medicine. Read More
The House of Representatives on Tuesday passed “right to try” legislation in a 250-169 vote despite warnings from House Democrats it would chip away at FDA authority. Read More
The FDA issued draft recommendations for designing and running a maximal usage trial (MUsT) for topical active ingredients that are being considered in an over-the-counter monograph. Read More
The complaint says Novartis agreed not to compete in the generic Exforge market from September 30, 2014 to March 30, 2015, leaving the generics market to Par. Read More