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FDA Updates RLD Access Inquiry List

[ Price : $8.95]

FDA updates its list of drugs for which the agency has received a reference-listed drug access inquiry.

Pelosi Releases Drug Pricing Bill

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House Speaker Nancy Pelosi releases her initial legislation to lower drug prices in ways she hopes will attract support from Presi...

Genentech Breakthrough Status for Lupus Nephritis Drug

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FDA grants Genentech a breakthrough therapy designation for Gazyva (obinutuzumab) for adults with lupus nephritis.

Meniscus Implant Gains Breakthrough Status

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FDA grants Active Implants a breakthrough device designation for the NUsurface Meniscus Implant.

FDA Releases Tech Modernization Plan

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FDA releases its long-awaited Technology Modernization Action Plan that describes short-term actions it is taking to modernize tec...

Development, Pre-Submission Meeting MAPP

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CDER issues a MAPP with policies and procedures for product development and pre-submission meetings with potential ANDA applicants...

FDA Guide on 505(q) Citizen Petitions

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FDA finalizes a guidance on drug-related citizen petitions and petitions for stay of action.

Info Collection Extension for Post-market Studies

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Federal Register notice: FDA seeks comments on an information collection extension for drug/biologic postmarketing studies status ...

CDRH Safer Technologies Program Introduced

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CDRH introduces its STeP safer technologies program.

Orphan Designation for Retinal Gene Therapy

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FDA grants an orphan drug designation for its novel gene therapy for treating the CEP290 mutation associated retinal disease.