Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost ...

More than 1,300 Chinese medical-device companies that registered to sell protective gear and other equipment in the U.S. during the coronavirus pandemic listed as their American representative a ...

Entries include information on each product, their manufacturer and date of the agency's approval. New tobacco products that received marketing authorization through one of FDA's three pathways to ...

On August 7, 2023, FDA issued a draft guidance document entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“The Draft Guidance”), providing FDA’s ...

Due to policies regarding industry user fees, the FDA will not be able to accept any new drug applications for the duration ...

The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation ...

LAUSANNE, Switzerland--(BUSINESS WIRE)--Abionic SA, a developer of disrupter nanotechnology based rapid diagnostic solutions, announced today that its rapid allergy test, IVD CAPSULE Aeroallergens, ...

WASHINGTON, November 26 - As the Food and Drug Administration (FDA) suspended the food facility registration of Portales, New Mexico-based Sunland Inc. Monday, worldwide concerns began to spread about ...

Augmedics has received the Food and Drug Administration (FDA) 510(k) clearance of the new CT-to-fluoroscopy (CT-Fluoro) registration method for its xvision spine system. Navigating off using ...

THE Food and Drug Administration (FDA) said Friday that it is set to release a new administrative order that would reduce the timeline of drug registration, especially among imported drugs that have ...