Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-48...
FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.
A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccine...
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare...
FDA sends Japanese active pharmaceutical ingredient maker Alps Pharmaceutical a Form 483 from an inspection that identified multiple manufacturing and...
Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the draft.
FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company failed to provide suffi...
FDA extends by three months its review of a Lantheus Holdings NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocrine tumors.
