FDA Related News

Medical Devices

FDA Warning on Shanghai Dasheng N95 Respirators

FDA alerts health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. due to quali...

Medical Devices

FDA Approves Mirena IUD Duration of Use sNDA

FDA has approved a Bayer sNDA extending to seven years the duration of use for the companys Mirena IUD birth control device.

Human Drugs

J&J Accumulating Data to Support Booster Vaccine

Johnson & Johnson says it has data supporting the use of its Covid-19 vaccine as a booster shot for people previously vaccinated with its single-shot ...

Medical Devices

EUA for BD Veritor At-Home Covid-19 Test

FDA issues an emergency use authorization for the BD Veritor at-home Covid-19 rapid antigen test that uses a smartphone camera to provide results of a...

Human Drugs

CGMP Violations at Natural Beauty Care

FDA warns Australias Natural Beauty of CGMP issues in its production of OTC drugs.

Biologics

Moderna Seeks Full Licensure for Covid Vaccine

Moderna completes a rolling BLA and requests a priority review for the submission seeking full licensure of its Covid-19 vaccine.

Federal Register

Info Collection on Data Monitoring Committees

Federal Register notice: FDA sends to OMB an information collection extension entitled Establishment and Operation of Clinical Trial Data Monitoring C...

Federal Register

Vaccines Advisory Committee Meeting 9/30

Federal Register notice: FDA announces a 9/30 Vaccines and Related Biological Products Advisory Committee meeting.

Medical Devices

Class 1 Recall of Alaris Infusion Pump Bezel Assembly

FDA classifies as Class 1 a Bio-Medical Equipment Service Co. recall of the Alaris Infusion Pump Module Model 8100 pump bezel assembly and Alaris infu...

PhRMA Updates Healthcare Professional Interaction Code

Two Hyman, Phelps & McNamara attorneys describe updates to the PhRMA Code on Interactions with Healthcare Professionals dealing with speaker programs.