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FDA Renews Advisory Committee Charters

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Federal Register Notice: FDA renews the charters of certain agency advisory committees.

FDA Approves Irokos Zorvolex for Osteoarthritis

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FDA approves an Iroko Pharmaceuticals supplemental NDA for Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug f...

Eisai Files NDA for Seizure Drug

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Eisai files an NDA for its antiepileptic drug Fycompa (perampanel) as an adjunctive treatment for primary generalized tonic-clonic...

Senate HELP Committee Draft of Sunscreen Bill

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The Senate Heath, Education, Labor and Pensions Committee has released for public comment a draft bill that would require FDA to s...

Fusilev Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Fusilev injection 175 mg/17.5 mL and 250 mg/25 mL were not withdrawn for reasons of s...

FDA Releases Action Plan on Demographic Trial Data

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Federal Register Notice: FDA makes available for comments an action plan as required by the the Food and Drug Administration Safet...

Guidance on Device Study Sex-Specific Data

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Federal Register Notice: FDA releases a guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies.

Workshop Planned on Contact Lens Disinfection

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Federal Register Notice: FDA will co-sponsor a public workshop 9/12 entitled Revamping Microbiological Test Methods for Contact Le...

FDA Proposes to Remove General Safety Test for Biologics

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Federal Register Proposed rule: FDA proposes to amend the biologics regulations by removing the general safety test requirements f...

FDA Targeting Informed Consent Revisions: Consultants

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Regulatory consultants firm the Weinberg Group says FDA will be paying close attention to the steps taken to revise clinical trial...