Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-483s issued following a CGMP inspection.
FDA warns India’s Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.
Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers respond to form FDA-483s issued following a CGMP inspection.
FDA warns India’s 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 vaccines and autism could endanger public health as measles cases climb nationwide.
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare orthopedic complication emerged in external studies.
