Federal Register notice: FDA makes available a draft guidance entitled Notification of a Permanent Discontinuance or Interruption in Manufacturing Und...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FDA issues a draft guidance recommending to applicants and manufacturers drug shortage information to be communicated to FDA to assist it in preventin...
The political newsletter Roll Call says efforts to reauthorize a pandemic preparedness bill are likely to include a debate over greater FDA oversight ...
FDA releases the form FDA-483 with three observations issued following an inspection at the Sugar Land, TX-based QuVa Pharma outsourcing facility.
