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Pharma Science/Clin Pharm Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an ...

Guide on Postmarketing Safety eSubmissions

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Federal Register notice: FDA makes available a final guidance entitled Providing Submissions in Electronic Format Postmarketing S...

MDIC Device External Evidence Framework

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The Medical Device Innovation Consortium publishes its framework on external evidence methods for medical devices based on input f...

Simulations Plus Finishes FDA Project

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Simulations Plus completes an FDA-funded project for a model-integrated design for bioequivalence studies in long-acting injectabl...

FDA Wants Authority to Require Superiority Data in NDAs

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FDA commissioner Robert Califf says the agency is considering asking Congress for additional authority to have the option of requi...

BIO Comments on Pediatric Cancer Drug Docket

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The Biotechnology Innovation Organization suggests ways for FDA to create a conceptual framework to inform decision-making for ped...

Moderna Seeks Vaccine EUA for Kids 6 Months to 6 Years

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Moderna is asking FDA for an emergency use authorization for its Covid-19 vaccine in children aged 6 months to 6 years old.

Lillys Tirzepatide Meets Trial Weight Loss Endpoints

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Lilly says its investigational weight-loss drug tirzepatide met all endpoints in the 72-week SURMOUNT-1 trial.

FDA Lifts Hold on Pfizer Duchenne Gene Therapy

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FDA lifts a clinical hold on Pfizers mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duche...

Risk Documents Key in Device Design: Column

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Retired Ethicon quality engineer Eric Hinrichs says medical device project design teams must document all risk assessments and how...