Drugindustrydaily

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Oct. 17, 2019

Vol. 18
No. 201

Headlines

Jury Selection Begins in Bellwether Opioid Trial, As Litigants Seek 11th Hour Settlements

Jury selection began on Wednesday in the Northern District of Ohio for the nation’s first federal bellwether trial in the opioid crisis, as more defendants scrambled to settle before the trial gets underway on Oct. 21. Read More

Antimicrobial Committee Supports NDA for Treating Complicated UTIs

The FDA’s Antimicrobial Drugs Advisory Committee voted 14-2 on Wednesday to support Shionogi’s NDA for cefiderocol lyophilized powder for IV administration to treat complicated urinary tract infection (cUTI). Read More

As Generic Approvals Break Records, Sharpless Promises to Help Continue the Trend

Acting FDA Commissioner Ned Sharpless announced that the agency once again approved a record number of generic drugs in fiscal 2019 and flagged upcoming actions to maintain the upward trend. Read More

FDA Finalizes Guidance on PDUFA Fee Waivers

The FDA outlined when sponsors can seek waivers, reductions or refunds of Prescription Drug User Fee Act (PDUFA) fees, in a final guidance released on Wednesday. Read More