Archive for May 2018

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Citing efficacy and other concerns, a joint FDA advisory committee voted 18-1 not to recommend approval of Insys’ buprenorphine spray for acute pain. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The FDA sent out a volley of warning letters to three U.S. distributors of kratom products for sales of unapproved new drugs claiming effectiveness in treating opioid addiction and withdrawal. Source: Drug Industry Daily

Former executives at Valeant and Philidor were convicted Tuesday of participating in a kickback scheme to ensure the drugmaker relied exclusively on Philidor for mail order pharmaceutical services. Source: Drug Industry Daily

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. Source: Drug Industry Daily

A North Carolina drug manufacturing facility is in the hot seat after an October FDA inspection found it was producing topical human drugs and pesticides using the same equipment. Source: Drug Industry Daily