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Repros to Meet With FDA on Androxal Phase 3 Trial

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FDA and Repros will meet 11/8 to review the companys plans for two Androxal Phase 3 studies to treat hypogonadism.

FDA San Juan Director Under Investigation, Sharfstein Says

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FDA principal deputy commissioner Josh Sharfstein tells a Congressional hearing that San Juan District director Maridalia Torres i...

Alliance for Stronger FDA Pushes for More Funding

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The Alliance for a Stronger FDA says it will continue to push for higher agency funding, especially given the potential for a hiri...

FDA Orders Unapproved Oral Colchicine Off the Market

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FDA orders drug manufacturers of unapproved single-ingredient oral colchicine, a medication used for treating gout and familial Me...

FDA 'Orphan' Status for Parasitic Drug

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FDA grants iCo Therapeutics an orphan drug designation for iCo-009 (oral amphotericin B) for treating visceral leishmaniasis.

Health Information Technology Study Includes FDA Role

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The Institute of Medicine contracts for a one-year study of health information technology in patient safety, including FDAs role.

Caution Urged on Regulating Lab Tests

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The American Clinical Laboratory Association and the Genetic Alliance urge FDA to use notice and comment rulemaking to develop a r...

Another Top CDRH Official Leaves the Agency

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CDRH 510(k) staff director Heather Rosecrans retires from the agency and joins other former FDAers at regulatory consulting firm G...

FDA Amends IND Safety Reporting Requirements

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Federal Register Final rule: FDA amends its regulations on safety reporting requirements for drugs and biologics subject to an inv...

Guidance on Safety Reporting for INDS and BA/BE Studies

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Federal Register Notice: FDA releases a draft guidance on safety reporting requirements for investigational new drugs and bioavail...