FDA Related News

Biologics

Millions of J&J Covid Doses in Storage: Report

Millions of J&J Covid vaccine doses are reported to be sitting in the Emergent facility in Baltimore waiting for FDA to authorize shipment.

Medical Devices

NeuroLogica AI Lung Nodule Detector Cleared

FDA clears a NeuroLogica 510(k) for its Auto Lung Nodule Detection (ALND) tool, a computer-assisted detection device for detecting pulmonary nodules.

Federal Register

Life Tech Covid Tests EUA Revoked

Federal Register notice: FDA announces the revocation of the Emergency Use Authorization issued to Life Technologies Corporation for the TaqPath Covid...

Medical Devices

Takeaways from FDA AI/ML Transparency Workshop

Two Morrison Foerster attorneys list five takeaways from an FDA virtual public meeting on artificial intelligence/machine learning transparency.

Human Drugs

FDA Efforts to Promote Safe Benzodiazepine Use

CDER associate director for controlled substances Marta Sokolowska shares issues raised at an FDA/Duke-Margolis Center for Health Policy workshop on s...

Human Drugs

Generally Positive Comments on PDUFA 7 Letter

Six stakeholders submit their comments on FDAs PDUFA 7 commitment letter.

Human Drugs

Cardinal Health Contract on Real World Evidence

FDA awards Cardinal Health a $750,000 contract to implement an 18-month real world evidence study to help the agency advance RWE in regulatory decisio...

Covid Brought FDA Focus on Real-World Data: Report

A Bloomberg Law report says FDA is likely to place greater emphasis on real-world data in future regulatory decisions.

Human Drugs

FDA OKs Labeling Change on Heart Failure Device

FDA approves a labeling modification on Impulse Dynamics Optimizer Smart medical device, allowing the removal of a normal sinus rhythm limitation from...

Medical Devices

Machine Learning Principles for Device Development

FDA joins with Canadian and UK regulators to promote 10 guiding principles for good machine learning practice for medical devices.