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FDA Safety Concern on Glaxo Myeloma BLA

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FDA reviewers raise safety concerns on a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory C...

REMS Modification, Revision Guidance

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FDA publishes a guidance on modifications and revisions to an approved REMS.

FDA Reg Review for Xepi Determined

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Toyama Chemical Co.s , Xepi...

Brain Metastases Patients in Cancer Trials

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Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Brain Metastase...

Guide on BPH Device Clinical Trials

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FDA issues a draft guidance on Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the...

Guide on Pediatric Patients in Cancer Trials

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Federal Register notice. FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Minimum Age Con...

Hypersensitivity Precaution Added to Olumiant

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FDA posts a drug safety-related labeling change for Eli Lilly and Incytes NDA for rheumatoid arthritis drug Olumiant to warn about...

Domestic FDA Inspections Resume

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FDA says it is planning to begin high-priority domestic inspections for medical products and other regulated products during the w...

Mylan, Fujifilm Kyowa Humira Biosimilar OKd

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FDA approves a Mylan and Fujifilm Kyowa Kirin Biologics Co. BLA for Hulio (adalimumab-fkjp), a biosimilar to AbbVies Humira (adali...

4 Cancer Clinical Trial Eligibility Criteria Guides

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FDA releases four cancer clinical trial eligibility criteria guidances for patients with hiv, hepatitis b or c virus infections, o...