FDA Related News

Federal Register

Comments Sought on eSubmitted Allegations to CDRH

Federal Register notice: FDA seeks comments on an information collection extension for Electronic Submission Process for Voluntary Allegations to the ...

Human Drugs

FDA Complete Response on Sunovion COPD Drug

FDA sends Sunovion Pharmaceuticals a Complete Response Letter on its NDA for SUN-101/eFlow (glycopyrrolate), indicated for treating chronic obstructiv...

Human Drugs

AstraZeneca Recalls 1 Lot of Brilinta

FDA says AstraZeneca is recalling one specific lot of Brinilta physician sample bottles after one was found with an additional drug in it.

Human Drugs

FDA Clears Masimo Pediatric Regional Oximetry

FDA clears a Masimo 510(k) for a pediatric indication for its O3 regional oximetry with an O3 pediatric sensor.

Human Drugs

Amgen Sues FDA for Sensipar Pediatric Exclusivity

Amgen sues to force FDA to grant it pediatric exclusivity for its thyroid drug Sensipar.

FDA Denies Mallinckrodt Inomax Petition Without Comment

FDA denies without comment a Mallinckrodt petition seeking changes with regard to applications referencing the companys Inomax nitric oxide product.

Human Drugs

Columnist Wants FDA Drug Innovation Support

A RealClear Health columnist calls on Congress to enact policies that promote drug innovation and change FDAs focus from drug and device approval to p...

Medical Devices

Zimmer Spinal Fusion Stimulator Recall Class 1

FDA says a Zimmer Biomet recall of implantable spinal fusion stimulators is Class 1.

Human Drugs

FDA Allows Expanded Use for Novartis Zykadia

FDA approves the expanded use of Novartis Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung canc...

Federal Register

FDA Vaccines Panel Meeting to Review Hep B Vaccine

Federal Register notice: FDA announces a 7/28 Vaccines and Related Biological Products Advisory Committee meeting that will vote on a Hepatitis B Vacc...