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Opportunity for Hearing on Withdrawal of 14 NDAs

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Federal Register Notice: FDA announces an opportunity to request a hearing on a proposal to withdraw approval of 14 NDAs.

Baylis TorFlex Sheath Kit Recall is Class 1

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FDA says a Baylis Medical recall of its TorFlex transseptal guiding sheath kits is Class 1.

Medical Device Trial Design Guidance Out

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CDRH issues a guidance on considerations for study design in medical device pivotal studies.

Curis Drug Placed on Partial Clinical Hold

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FDA places on partial clinical hold a Curis Phase 1 clinical trial of its oral inhibitor of apoptosis antagonist, CUDC-427 due to ...

Guidance on BE Recommendations for Iron Sucrose

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Federal Register Notice: FDA releases a draft guidance on bioequivalence recommendations for iron sucrose.

FDA Releases Additional Product-Specific BE Recs

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Federal Register Notice: FDA releases additional draft and revised draft product-specific bioequivalence recommendations to suppor...

CDRH Posts Proposed FY 14 Guidances

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Federal Register Notice: CDRH announces the Web site location for proposed fiscal year 2014 guidance documents.

FDA Approves W.L. Gore Viabahn Endoprosthesis

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FDA approves a W. L. Gore PMA for its 25 cm Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for treating symptomatic pe...

Abbott Loses Bid to Move Humira Lawsuit to Federal Court

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A Maryland federal judge rules against Abbott in its request to move a Humira (adalimumab) personal injury lawsuit from state to f...

CBS News Profiles Ranbaxy Whistleblower

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CBS News profiles the Ranbaxy whistleblower to led FDA to find hundreds of data errors in ANDAs for more than 15 drugs.