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Breakthrough, Orphan Drug Status for PellePharm Drug

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FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorli...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 11/17/2017.

Guide on Cell/Tissue-Based Product Regulatory Considerations

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FDA releases a guidance on Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Mi...

Rep. DeLauro Seeks Ban on DTC Ads, Again

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Congresswoman Rosa DeLauro (D-CT) reintroduces a bill (HR 4385) that would amend the Food, Drug, and Cosmetic Act to restrict dire...

Docket Number Correction for ANDA Controlled Correspondence

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Federal Register notice: FDA corrects an 11/3 Federal Register notice entitled Controlled Correspondence Related to Generic Drug D...

Expedited Programs for Regenerative Medicines Draft Guidance

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Federal Register notice: FDA makes available a draft guidance on Expedited Programs for Regenerative Medicine Therapies for Seriou...

FDA Panel Votes Down Bayers Ciprofloxacin for Bronchiectasis

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FDAs Antimicrobial Drugs Advisory Committee votes 9 to 6 against recommending approval for Bayer HealthCare Pharmaceuticals ciprof...

Pfizers Greenstone Recalls Super/Sub Potent Drugs

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Pfizer subsidiary Greenstone recalls multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the product...

Gottlieb Steps in to Ease Hospital Product Shortages

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FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricane...

Direct Device Marking Guidance

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FDA issues a guidance answering questions about the direct marking of medical devices under the unique device identification regul...