[ Price : $8.95]
FDA sends Japanese active pharmaceutical ingredient maker Alps Pharmaceutical a Form 483 from an inspection that identified multip...[ Price : $8.95]
Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the ...[ Price : $8.95]
Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers re...[ Price : $8.95]
FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company fai...[ Price : $8.95]
FDA extends by three months its review of a Lantheus Holdings NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocri...[ Price : $8.95]
A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered...[ Price : $8.95]
FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India...[ Price : $8.95]
FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.