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Groups Want Stronger Post-Market Trial Enforcement

[ Price : $8.95]

U.S. PIRG and other advocacy groups urge that stricter enforcement of post-market clinical trials for accelerated approval drugs b...

Antibacterial Therapy Q&A Guidance

[ Price : $8.95]

FDA publishes a draft guidance with questions and answers on developing antibacterial therapies for patients with an unmet medical...

Vanda Sues FDA to Overturn Fast Track Rejection

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Vanda Pharmaceuticals asks the DC federal court to set aside an FDA determination that the companys tradipitant does not qualify f...

RapidAI Pulmonary Embolism Identifier Cleared

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FDA clears a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism.

INmune Bio Clinical Hold on TNF Therapy

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FDA places a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF...

Aurobindo Pharma FDA-483

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FDA releases the FDA-483 with six observations from an inspection at Indias Aurobindo Pharma drug manufacturing facility.

Groups Suggest Changes to Device Quality System Reg

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Four medical device stakeholders voice general support for an FDA proposal to harmonize the medical device Quality System Regulati...

CDER Research Helping Generic Inhaler Development

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CDER researchers describe a study of mouth-throat models for generic metered-dose inhalers to help generic inhaler manufacturers m...

Teva Recalls 1 Lot of Anagrelide Capsules

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FDA says Teva recalled one lot of anagrelide capsules due to dissolution test failure.

Guide on Non-inferiority Trials for Antibacterials

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Federal Register notice: FDA makes available a draft guidance entitled Antibacterial Therapies for Patients with an Unmet Medical ...