Posts Tagged ‘ADCOM’
My Testimony Before the ADCOM for AcelRex’s DSUVIA
On Friday, Oct. 12, 2018, AcelRex Pharmaceuticals, Inc. presented its case to the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (ADCOM) to discuss the approval of the new drug application (NDA) 209128 for DSUVIA™. DSUVIA is a small sufentanil pill deposited below the tongue with an applicator. It is…
Read MorePreparing for an FDA Advisory Committee Meeting: What You Need to Know
Mark Twain is quoted as saying: “If I had more time, I would have written a shorter letter.” What Is an FDA ADCOM? Pharma and device companies seeking approval for their products are often required to present their data to an FDA advisory committee meeting (ADCOM). They have a limited time in which to tell…
Read More