District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

		The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Continue reading...

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas. Continue reading...

FDA IN BRIEF: FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernize drug development and promote innovation in drugs targeted to unmet needs

Today, the U.S. Food and Drug Administration announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which drug and biologic companies who participate in the pilot program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs. Complex innovative trial designs includes the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determiniations, and other novel designs. The new program is aimed at helping to solidify the science used to support these novel approaches, and promote their adoption in drug development programs where these trial constructs can advance innovation. Continue reading...

FDA Law Blog--

Facing Continuation of the Endo/Par Vasopressin Lawsuit, FDA Publishes Notice Concerning List of Drug Substances for Which there is [NOT?] a Clinical Need under Section 503B

Posted: 28 Aug 2018 08:05 AM PDT

By Karla L. Palmer —