Technology receives FDA approval for breast cancer treatment

More than a decade ago, Yale chemist Craig Crews founded a biotechnology company in New Haven based on his pioneering ...
Regulatory Affairs Professionals Society

MedCon: FDA, industry experts discuss best practices for managing software defects, anomalies

The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is ...
Nextgov

FDA launches updated AI and consolidated data platform

The Food and Drug Administration’s flagship internal AI tool, Elsa, is being integrated with the data platform so that staff ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
Texas Public Radio

Psychedelic treatments are on the verge of FDA approval. Why Texas is pushing for them, and how Texans could gain access

Texas is helping shape the future of psychedelic therapies. Here’s how they work and what access could look like.
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of ...