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In a long-awaited report on the post-surgical quality of LASIK patients, FDA downplays the harms it found in up to 45% of 572 pati...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on CGMP requirements for blood and blood compo...[ Price : $8.95]
Federal Register Notice: FDA issues an order debarring Kelvin Soto for a period of six years from any contact to a person with an ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections...[ Price : $8.95]
Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) write HHS secretary Sylvia Burwell asking her to address significant...[ Price : $8.95]
CDRH posts a resources listing for medical device makers submitting an electronic copy of their submissions.[ Price : $8.95]
Hospira recalls one lot of 1% lidocaine HCl for injection due to a confirmed customer report about particulate in a single unit.[ Price : $8.95]
CDER eclipses last years 27 new molecular entity (NME) drug product approvals by approving 34 applications through 10/15.