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Federal Register

Info Collection on Radioactive Research Committees

Federal Register notice: FDA seeks comments on an information collection extension for Radioactive Drug Research Committees21 CFR 361.1.

Federal Register

Info Collection on Customer Service Surveys

Federal Register notice: FDA seeks comments on an information collection extension for Customer/Partner Service Surveys (OMB Control Number 09100360)....

Medical Devices

CureWave Lasers Marketing Unapproved Device: FDA

FDA warns CureWave Lasers about multiple violations in its manufacturing and marketing of laser products.

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.