FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.
Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-labeled carbon), indicate...
Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated for treating seizures ...
CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer advertisement for m...
FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.
FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.
The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence determination of a ...
FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocaliva to treat some cas...
