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Advisors Recommend New Humira Indication

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FDA advisors say that Humiras benefits in treating ulcerative colitis outweigh its risks.

Battle for FDA Webview Surges Inside Agency

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FDA Webview editor Jim Dickinson attracts strong support in his battle to keep providing FDA employees with the unique interactive...

Genentech Files BLA for Trastuzumab Emtansine for Breast Cancer

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Genentech files a BLA for trastuzumab emtansine, seeking approval to treat people with HER2-positive metastatic breast cancer.

Q&A Guidance on Generic Drug User Fee Amendments

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FDA posts a draft guidance on questions and answers related to generic drug user fees.

FDA Not Concerned About DepoCyte After EU Recall

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CDER officials say they are not too concerned with European inspection findings and a subsequent recall involving Pacira Pharmaceu...

FDA Refuses to Review Genzyme sBLA for Lemtrada

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FDA slaps Genzyme with a refuse-to-file letter on a supplemental BLA for Lemtrada (alemtuzumab) as a treatment for relapsing multi...

Gilead Sciences HIV Drug Stribild Approved

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FDA approves a Gilead Sciences NDA for Stribild, a once-a-day combination pill to treat HIV-1 infection in adults.

FDA Lifts Clinical Hold on Wet AMD Drug

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FDA lifts a clinical hold against Lpath and its iSonep, an anti-S1P monoclonal antibody that is being developed as a potential tre...

Guidance on Self-Identification of Generic Drug Facilities

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FDA releases a draft guidance on the self-identification requirement under generic drug user fee act.

Goodbye! FDA Shuts the Door (Again) on Our Village Square

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Closing a 38-year interactive connection with rank-and-file FDA employees, FDA Webview editor Jim Dickinson says goodbye to FDA em...