Thursday, March 28, 2024

Thursday, March 28, 2024

Latest News

Revamped FDA website to launch this week

Food and Drug Administration Acting Commissioner Ned Sharpless announced a new FDA.org website to launch this week.

Responsible innovation in dietary supplements to be discussed at FDA public meeting

As part of a continuing effort to modernize and reform the oversight of dietary supplements, the Food and Drug Administration announced a public meeting on May 16 from 8:30 a.m. to 4 p.m. to canvass ideas on facilitating responsible innovation.

FDA assesses duoenoscope contamination risk

The Food and Drug Administration oversees manufacturers’ postmark surveillance studies on new and significant health concerns in order to understand a device’s risks and to update policies on such risks.

Female hypoactive sexual desire disorder drug Addyi to have labeling updated on mixing with alcohol

A labeling change order was issued to Sprout Pharmaceuticals last week by the Food and Drug Administration concerning its drug Addyi (flibanserin).

FDA gives clearance for Scientific Analytics and Hospital for Special Surgery for computer-vision collaboration

The FDA gave 510(k) medical device designation to Scientific Analytics (SAI) for DARI Health, a computer-vision-powered motion analysis technology.

Three-minute 'Theta Burst' treatment cleared by FDA

The FDA has cleared a new treatment for major depressive disorder.

FDA clears Selvita to conduct Phase 1 study for acute myeloid leukemia

The FDA will allow Selvita to conduct a Phase 1 study on an Investigational New Drug for acute myeloid leukemia or high-risk myelodysplastic syndrome.

FDA seeks to reform clinical trials

SILVER SPRING, Md. -- The Food and Drug Administration (FDA) wants to overhaul the current clinical trial process by giving patients, doctors and researchers clearer access to clinical trial information, according to a new FDA statement released by former FDA Commissioner Dr. Scott Gottleib, current FDA director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, and current chief of staff to the FDA commissioner, Lauren Silvis.

FDA Reporter