FDA Related News

Human Drugs

Device Compliance Official Flags Quality Gaps, Rising Enforcement

A senior CDRH compliance official warns industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting ...

Biologics

Panel Votes to End Newborn Hepatitis B Shot Recommendation

CDCs Advisory Committee on Immunization Practices votes to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine withi...

Human Drugs

FDA 483 Cites Apotex Over Sterility, Data Integrity Failures

FDA investigators issue a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotexs sterile drug facil...

Human Drugs

Praxis Epilepsy Drug Study Stopped for Positive Efficacy

Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committe...

Medical Devices

FDA Advisers Reject J&Js V-Wave Heart Shunt

An FDA advisory committee votes unanimously against recommending approval of Johnson & Johnsons V-Wave heart shunt for patients with advanced heart fa...

Human Drugs

Breyanzi OKd for Hard-to-Treat Marginal Zone Lymphoma

FDA approves Juno Therapeutics CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma.

Medical Devices

Medical Device eCopy Submission Guidance

FDA publishes a guidance on implementing the eCopy submission program for medical devices.

Medical Devices

FDA, CMS Launching Tempo Pilot

FDA launches a pilot with the Center for Medicare and Medicaid Innovation to promote access to certain digital health devices covered through a new Ce...

Human Drugs

User Fees Could Incentivize U.S. Drug Development

FDA reportedly is exploring ways PDUFA fees can be adjusted to incentivize companies to hold clinical trials in the U.S. rather than overseas.

Quarter 3 Drug and Device Recalled Units Higher: Sedgwick Index

The Sedgwick third-quarter recall index sees a sharp increase in the number of affected drug and medical device units.