The Federal Trade Commission says it shares FDA concerns about abuse of the citizen petition process to delay approval of generic drugs and will work ...
FDA releases its latest batch of Warning Letters that include Barox Co., Globus Medical and MiBo Medical Group.
FDA issues a proposed rule to change the submission and review requirements for the medical device de novo classification pathway.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Aspire Bariatrics medical device Aspire Assist....
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Synergy Pharmaceuticals Trulance (plecanatide)....
FDA determines for patent extension purposes the regulatory review period for Intercept Pharmaceuticals Ocaliva (obeticholic acid).
FDA warns MiBo Medical Group about Quality System violations in its manufacturing of the MiBo Thermoflo.
FDA warns Koreas Barox about CGMP violations in its production of finished drugs.