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…
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.…
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…
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.…
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…
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:…
Avadel Specialty Pharmaceuticals called on the FDA to deny approval for certain demopressin acetate treatments for nocturia, including a pending drug application by Ferring, expressing concern over the pharmaceutical company’s…
New guidance from the FDA on bioanalytical method validation revises a 2013 document with expanded principles and new appendices on documentation and acceptance criteria. Source: Drug Industry Daily