Simplifying Global Compliance
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Oct. 17, 2019
Vol. 18
No. 201
Headlines
Full Issue of Drug Industry Daily
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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
