CBER issues an untitled letter to Fidia Pharma USA after reviewing the companys Web sites and determining that its cell/tissue products require a BLA ...
Federal Register notice: FDA makes available a draft guidance on incorporating clinical outcome assessments into endpoints.
Federal Register notice: FDA makes available a draft guidance entitled Notification of a Permanent Discontinuance or Interruption in Manufacturing Und...
FDA commissioner Robert Califf and chief scientist Namandj Bumpus withdraw Covis Pharmas preterm birth drug Makena and its generics from the market ef...
FDA clears a restor3d 510(k) for the Axiom PSR System for use with the companys Kinos Axiom Total Ankle System.
The Justice Department says two Texas men face up to five years in prison after pleading guilty to selling misbranded drugs over the Internet.
FDA accepts for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roches Herceptin) biosimilar for treating certain patients with brea...
FDA issues a draft guidance recommending to applicants and manufacturers drug shortage information to be communicated to FDA to assist it in preventin...
