FDA Related News

Human Drugs

OCE Soliciting Crowdsourced Research Input

The FDA Oncology Center of Excellence says it is using crowdsourcing to generate possible research questions for agency scientific staff to pursue usi...

FDA Extends Review of Verrica Pharmaceuticals NDA

FDA extends by three months its review of Verrica Pharmaceuticals NDA for VP-102 (cantharidin), a combination drug-device for treating molluscum conta...

Medical Devices

CGMP Issues in DeChoker Inspection

FDA warns DeChoker about Quality System regulation violations in its production of a tracheobronchial suction device.

Federal Register

Sandostatin Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Novartis Sandostatin (octreotide acetate) injection was not withdrawn for safety or effectiveness reasons...

Human Drugs

False Results Warning on 2 Covid Tests

FDA issues a safety communication warning against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibod...

Medical Devices

Medical Device Companies Need Closed-Loop Traceability: Column

Greenlight Guru founder Jon Speer says medical device companies should use a quality management system solution to maintain closed-loop traceability a...

Human Drugs

OCE Marks National Black Family Cancer Awareness Week

The FDA Oncology Center of Excellence says it will mark its inaugural National Black Family Cancer Awareness Week 6/17-6/23.

Human Drugs

HHS Asks Court to Dismiss Drug Import Suit

HHS asks the DC federal court to dismiss a stakeholder suit seeking to bar the agency from implementing a Section 804 drug importation program.

Biologics

Moderna Seeking Covid Vaccine Full Approval

Moderna begins a rolling BLA for its mRNA Covid-19 vaccine for use in individuals 18 years of age and older.

Some OPDP eCTD Submissions Mandatory on 6/24

FDA posts a notice giving 6/24 as the effective date for certain specified OPDP submissions to be in the eCTD format.