FDA Related News

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.

Human Drugs

Lilly Cancer Drug Misses Endpoint

Lilly says its pancreatic cancer drug misses its primary endpoint in a Phase 3 trial.

Medical Devices

HHS Inspector General Assessing Device Surveillance

HHSs Office of Inspector General says it is assessing FDAs medical device postmarket surveillance activities.

Human Drugs

ViiV sNDA for Dovato as a Switch Treatment

ViiV Healthcare submits a supplemental NDA for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection.

Medical Devices

Improving Dental Device 510(k) Submissions

A CDRH Webinar discusses issues seen in dental device 510(k) submissions and ways in which they can be improved.