FDA Related News

Human Drugs

Panel Backs Shionogo Urinary Tract Infection Drug

An FDA advisory committee votes 14 to 2 to recommend approval of a Shionogi NDA for cefiderocol injection for its proposed indication to treat complic...

Human Drugs

Ipsen Asks Somatuline ANDA Restrictions

Ipsen asks FDA to require in vivo bioequivalence for any ANDA citing its Somatuline Depot as the reference-listed drug.

Medical Devices

Fidmi Medical Enteral Feeder Cleared

FDA clears a Fidmi Medical 510(k) for its low-profile enteral feeding device.

Human Drugs

Greenleaf Adds Good Clinical Practice Services

Greenleaf Health adds good clinical practice services to its range of FDA regulatory consulting.

Human Drugs

Firm Gets Breakthrough Status for Prostate Cancer Test

FDA grants Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test.

FDA General

Nonvoting Rep Sought for Tobacco Science Panel

Federal Register notice: FDA requests nominations for a nonvoting representative to serve on the Tobacco Products Scientific Advisory Committee.

Human Drugs

FDA Sets Record in Generic Drug Approvals

FDA acting commissioner Ned Sharpless says FDA has set a record for generic drug approvals in FY 2019.

FDA Tobacco Ad Rule Violates 1st Amendment: WLF

Washington Legal Foundation cites a drug advertising court case in arguing that a proposed FDA tobacco labeling rule violates the First Amendment.

Human Drugs

PDUFA User Fee Waiver Guidance

FDA issues a revised guidance on PDUFA user fee waivers, reductions, and refunds.

Human Drugs

H.R. 3 Amendments Not Enough: Public Citizen

Public Citizen says new amendments to the House drug price legislation are an improvement but dont go far enough.