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...

Medical Devices

Piccolo Medical SmartPICC System Cleared

FDA clears a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate peripherally insert...

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.