Federal Register notice: FDA issues an order to debar Phillip Leonowens for a period of five years from importing or offering for import any drug into...
Federal Register notice: FDA announces support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implem...
FDA issues a revised final and draft guidance on the handling and retention of BA and BE testing samples.
FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Institute.
Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease following favorable...
FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after ...
Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for...
CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform regulatory decision-ma...
