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Reviewers Question Data on Capricor's Duchenne Cardiomyopathy Cell Therapy

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FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duc...

Final Guidance on Washout Periods in Cancer Clinical Trials

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FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomita...

Laboratory Value-Based Eligibility Criteria in Cancer Trials Guidance

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A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unn...

FDA to Hold Webinar on Proposed Expedited IND Pilot Program

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FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investig...

FDA Advisers Back Expanded Access to Several Compounded Peptides

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An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the ag...

Amgen New Data Pushes Back Against Proposal to Withdraw Tavneos

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Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatmen...

FDA Rejects Apiject's NDA for Glycopyrrolate Combination Product

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FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate soluti...

FDA Early Alert Over Boston Scientific Transcarotid Catheter Systems

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FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transc...

FDA cites Bausch + Lomb Manufacturing Facility

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FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility i...

FDA: PDUFA 7 CMC Commitments Complete

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FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...