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Federal Register

Consumer Reps Sought for Advisory Panels

Federal Register notice: FDA requests that any consumer organizations interested in participating in selecting voting or nonvoting consumer representa...

Federal Register

FDA Rare Disease Day Public Meeting

Federal Register notice: FDA announces a 2/24 public meeting on FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development....

Federal Register

Info Collection on Drug Names Study

Federal Register notice: FDA seeks comments on a new information collection entitled Empirical Study of Promotional Implications of Proprietary Prescr...

Federal Register

Latest Federal Register Notices

FDA Review has posted the Federal Register notices for the week ending 1/17/2020.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 1/18/2020.

Human Drugs

Ozempic OKd for Reducing Major Cardio Events

FDA approves a new indication for Novo Nordisks Ozempic (semaglutide) injection 0.5 mg or 1 mg reducing the risk of major adverse cardiovascular even...

Can a Name Misbrand a Drug? FDA Study

FDA seeks comments on new proposed research by CDERs Office of Prescription Drug Promotion on promotional implications of proprietary drug names.

Human Drugs

FDA Panel Split on Durect Pain Drug

FDAs Anesthetic and Analgesic Drug Products Advisory Committee issues a split vote (6 to 6) on the approval of Durect Corp.s surgical pain drug Posimi...

Federal Register

CDRH Radiation Safety Panel Seeks Members

Federal Register notice: FDA requests nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committee.

Medical Devices

Move Away from Traditional Duodenoscopes: FDA

A new FDA safety communication recommends that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer ...