FDA Related News

Human Drugs

Generic Drug Controlled Correspondence Guidance

FDA publishes a guidance on how generic drug manufacturers can submit controlled correspondence to FDA seeking generic drug development information.

Federal Register

Priority Review Voucher Awarded to Eiger BioPharm

Federal Register notice: FDA issues of a priority review voucher to Eiger BioPharmaceuticals that is related to its rare pediatric disease product NDA...

Human Drugs

FDA Advisors Back Greater Entresto Use

FDA advisors back an expanded indication for Novartis heart failure drug Entresto but cant specify a patient group.

Medical Devices

ACL Implant Gains De Novo Authorization

FDA grants a de novo marketing authorization for Miach Orthopedics anterior cruciate ligament (ACL) implant for ACL reconstruction in patients with AC...

Medical Devices

Abbott Virtual At-Home Covid Test Gets EUA

FDA issues Abbott an Emergency Use Authorization for its virtually guided at-home use BinaxNOW Covid-19 Ag Card rapid test for detecting Covid-19 infe...

Human Drugs

Develop Clinical Trial Data Strategy: Consultants

YourEncore consultants describe in a white paper the value of having a clinical trial data strategy.

Grassley, Wyden Track Company Payments to Pain Groups

Sens. Grassley and Wyden call for greater transparency in regulated industry payments to tax-exempt advocacy groups.

Human Drugs

15 Observations in Advanced Nutriceuticals FDA-483

FDA releases the FDA-483 detailing 15 inspection observations from an inspection at Advanced Nutriceuticals, a sterile drug product producer.

Medical Devices

EMD Serono Comments on Cybersecurity Communications

EMD Serono suggests ways to improve an FDA discussion paper on communicating cybersecurity vulnerabilities to patients.

Biologics

Feds Discuss Pfizer Vaccine Manufacturing Issues

Federal officials report to the media that Pfizer is experiencing some vaccine manufacturing issues.