FDA warns Amazon.com it is distributing unapproved new drugs.
FDA warns Fort Worth, TX-based Sovereign Pharmaceuticals about CGMP violations in its manufacturing and distribution of an unapproved biologic product...
Two drug stakeholder associations raise questions and suggest changes to an International Council for Harmonization draft guidance on pediatric extrap...
FDA issues an updated question-and-answer draft guidance on expanded access to investigational drugs for treatment use.
A citizen petition asks FDA not to approve any Technetium-99m product produced through neutron capture in a conventional generator.
FDA warns Indias Lupin Limited about CGMP deviations in the production of active pharmaceutical ingredients.
FDA researchers say industry use of the accelerated approval, breakthrough therapy, fast track, and priority review programs has increased since 2008 ...
FDA says it is deferring action on an Amicus BLA for cipaglucosidase alfa as part of a treatment for Pompe disease until the agency can conduct a manu...
