Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.
The US Food and Drug Administration asked stakeholders for input on whether pre-approval incentives are needed to encourage the development of new analgesic products, and industry responded by providing the agency with a slew of proposals to consider.
At a 17 September FDA public meeting on standards for future opioid analgesic approvals and incentives for new therapeutics to treat pain and addiction, several industry
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
