FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.
FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare...
Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures ...
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Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the draft.
Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-48...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 sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company failed to provide suffi...
