FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
Scientific American

Health Experts Slam Possible FDA ‘Black Box’ Warning for COVID Vaccines

The U.S. Food and Drug Administration is reportedly weighing whether it will place a “black box” warning label on COVID vaccines, according to CNN, despite research and real-world data demonstrating ...
Bloomberg L.P.

FDA Slow Walking a Long-Awaited Abortion Pill Safety Study

The drug is used in nearly two-thirds of US abortions and for miscarriage management, according to the American Civil Liberties Union, which estimates that roughly 7.5 million Americans have taken the ...
GitHub

Nitrosamine datasets and codes

This is the repository of the jounal paper titled "Integrating Explainable Artificial Intelligence and Carcinogenic Potency Characterization for Safer Nitrosamine Risk Assessment in Drug Synthesis." ...
STAT

FDA review staff was excluded from voting on whether to approve first priority voucher drug

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...
Morningstar

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives FDA Approval as a Companion Diagnostic to Identify Patients Eligible for Newest Targeted Therapy for Non-Small ...

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives FDA Approval as a Companion Diagnostic to Identify Patients Eligible for Newest Targeted Therapy for Non-Small Cell Lung Cancer Test will ...
The Columbian

The FDA removes a long-standing warning from hormone-based menopause drugs

WASHINGTON — Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food ...