Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications
In January 2020, two FDA committees met to consider approval of three opioid-related new drug applications.
Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications

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In January 2020, two FDA committees met to consider approval of three opioid-related new drug applications.

By Ron Litman This year I began a two-year appointment as Chair of the FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC). Our committee is asked to convene several times a year to discuss and…

Anesthesiologists are the only type of healthcare provider that prescribes, dispenses, premixes, repackages, relabels, and administers the medications, independently and without secondary verification or use of technologic support.

By Ron Litman Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15,…

By Ron Litman The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil,…
