Zdrowie i gospodarka · 22/04/2014
Postmarketing Requirements for the Class-Wide Extended-Release/Long-Acting Opioid Analgesics; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting to obtain stakeholder input on the design and conduct of the postmarketing requirements (PMRs) for the class-wide extended-release/ long-acting (ER/LA) opioid analgesic drug products to further assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with their long-term use. FDA is seeking input on these issues from stakeholders, including patients, academia, researchers, State and other Federal regulators, health care organizations, health care providers, the pharmaceutical industry, and others from the general public.