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CDRH issues a guidance on considerations for study design in medical device pivotal studies.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on bioequivalence recommendations for iron sucrose.[ Price : $8.95]
Federal Register Notice: FDA releases additional draft and revised draft product-specific bioequivalence recommendations to suppor...[ Price : $8.95]
Federal Register Notice: CDRH announces the Web site location for proposed fiscal year 2014 guidance documents.[ Price : $8.95]
FDA approves a W. L. Gore PMA for its 25 cm Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for treating symptomatic pe...[ Price : $8.95]
A Maryland federal judge rules against Abbott in its request to move a Humira (adalimumab) personal injury lawsuit from state to f...[ Price : $8.95]
CBS News profiles the Ranbaxy whistleblower to led FDA to find hundreds of data errors in ANDAs for more than 15 drugs.[ Price : $8.95]
A new CDRH Web site places developing a draft guidance on Benefit-Risk Determinations in Premarket Notifications (510(k)s) as one ...