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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...[ Price : $8.95]
Federal Register Notice: FDA seeks industry participants for selecting a tobacco grower representative for the Tobacco Products Ad...[ Price : $8.95]
Foley & Larder reports that a complaint on behalf of Par against potassium chloride powder product imports moves to an administrat...[ Price : $8.95]
The DC federal court rules in FDAs favor in a lawsuit brought by Otsuka that sought to reverse the agencys approval of Alkermes 50...[ Price : $8.95]
FDA approves a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combin...[ Price : $8.95]
CDRH posts a Medical Device Single Audit Program document that outlines the control of quality records generated under the pilot p...[ Price : $8.95]
FDA grants Shire a fast track designation for SHP626 (volixibat), an investigational drug for treating adults who have nonalcoholi...[ Price : $8.95]
A CDRH webinar reviews medical device biocompatibility issues addressed in a recent a guidance on Use of International Standard IS...