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TXT Pharma Science/Clin Pharm Panel Renewed [65 Words] [ Price : $8.95]
Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years.
04/28/2022
 
 
TXT Guide on Postmarketing Safety eSubmissions [85 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Providing Submissions in Electronic Format — Postmarketing Safety Reports.
04/28/2022
 
 
TXT MDIC Device External Evidence Framework [2715 Words] [ Price : $8.95]
The Medical Device Innovation Consortium publishes its framework on external evidence methods for medical devices based on input from FDA and other stakeholders.
04/28/2022
 
 
TXT Simulations Plus Finishes FDA Project [2629 Words] [ Price : $8.95]
Simulations Plus completes an FDA-funded project for a model-integrated design for bioequivalence studies in long-acting injectable drugs.
04/28/2022
 
 
TXT FDA Wants Authority to Require Superiority Data in NDAs [803 Words] [ Price : $8.95]
FDA commissioner Robert Califf says the agency is considering asking Congress for additional authority to have the option of requiring drug sponsors in their NDAs to demonstrate their product’s superiority over drugs that are already on the market.
04/28/2022
 
 
TXT BIO Comments on Pediatric Cancer Drug Docket [2683 Words] [ Price : $8.95]
The Biotechnology Innovation Organization suggests ways for FDA to create a conceptual framework to inform decision-making for pediatric cancer drugs.
04/28/2022
 
 
TXT Moderna Seeks Vaccine EUA for Kids 6 Months to 6 Years [2664 Words] [ Price : $8.95]
Moderna is asking FDA for an emergency use authorization for its Covid-19 vaccine in children aged 6 months to 6 years old.
04/28/2022
 
 
TXT Lilly’s Tirzepatide Meets Trial Weight Loss Endpoints [2684 Words] [ Price : $8.95]
Lilly says its investigational weight-loss drug tirzepatide met all endpoints in the 72-week SURMOUNT-1 trial.
04/28/2022
 
 
TXT FDA Lifts Hold on Pfizer Duchenne Gene Therapy [382 Words] [ Price : $8.95]
FDA lifts a clinical hold on Pfizer’s mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy.
04/28/2022
 
 
TXT Risk Documents Key in Device Design: Column [2759 Words] [ Price : $8.95]
Retired Ethicon quality engineer Eric Hinrichs says medical device project design teams must document all risk assessments and how the risks have been mitigated or eliminated.
04/28/2022
 
 
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