FDA Related News

Biologics

FDA Snubs Brainstorm ALS Therapy Data

FDA tells BrainStorm Cell Therapeutics that current Phase 3 data will not demonstrate substantial evidence to support a BLA for NurOwn (autologous MSC...

Modifying Vaccines, Tests Due to Variants: Woodcock

FDA acting commissioner Janet Woodcock announces updated guidance for currently authorized Covid-19 vaccines and diagnostic tests that could be modifi...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 2/19/2021.

Federal Register

Stakeholder Participation in Device User Fee Talks

Federal Register notice: FDA requests notification from public stakeholders of their intent to participate in periodic consultation meetings on reauth...

Federal Register

Covid-19 Guidance Documents Availability

Federal Register notice: FDA announces the availability of recent guidance documents related to the Covid19 pandemic.

Federal Register

FDA Updates Records for Recent EUAs

Federal Register notice: FDA updates its records to reflect five recent Emergency Use Authorizations for drug and biological products for use during t...

Human Drugs

Pfizer/BioNTech Seek Warmer Vaccine Storage Approval

Pfizer and BioNTech submit new stability data to FDA to permit their Covid-19 vaccine vials to be stored at warmer temperatures than their original au...

Medical Devices

Safety Alert on Pulse Oximeters

FDA issues a safety alert on the limitations of pulse oximeters.

Medical Devices

FDA Clears FX Shoulder 510(k) for Shoulder Prosthesis

FDA clears an FX Shoulder 510(k) for the Easytech Stemless Anatomic, a shoulder prosthesis featuring primary peripheral fixation.

Human Drugs

4% of CDER Submissions Get Refuse-to-File Letter

An FDA study of refuse-to-file (RTF) letters finds that 4% of CDER submissions from 2008 to 2017 were issued an RTF.