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FDA says that extrapolating efficacy data from studies conducted in adults to the pediatric population can help increase the numbe...[ Price : $8.95]
CDER issues a MAPP on how staff will verify applicants reported status on postmarketing requirements and commitments.[ Price : $8.95]
The Association for Molecular Pathology expresses concern in comments to an FDA draft guidance on in vitro companion diagnostic de...[ Price : $8.95]
FDA clears a St. Jude Medical 510(k) for its Ilumien system, an integrated diagnostic technology intended to help improve coronary...[ Price : $8.95]
Federal Register Notice: FDA corrects a Web and e-mail address in a Federal Register notice seeking device sponsors to participate...[ Price : $8.95]
FDA posts two FDA-483 inspection reports for a troubled Hospira manufacturing plant while the company updates financial analysts o...[ Price : $8.95]
Newly-appointed FDA deputy commissioner for medical products and tobacco Stephen Spielberg explains he does not intend to microman...[ Price : $8.95]
The Department of Justice takes parallel action to a controversial HHS news media policy by also formalizing a longestablished inf...