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United States - Life Sciences, Biotechnology & Nanotechnology - FDA Provides Updates To Congress On FDORA, User Fee Implementation

FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements. ....

Diana Degette , Jeff Shuren , Patrizia Cavazzoni , Peter Marks , Frank Pallone Jr , Larry Bucshon , Radiological Health , Device Regulators Forum , Laboratory Developed Tests Ldts , Medicaid Services , Drug Administration , Ecommerce Health , House Energy , Drug Evaluation , Director Patrizia Cavazzoni , Director Peter Marks , Director Jeff , Drug Omnibus , Reform Act , Approval The , Trial Modernization , Diversity Action , Fee Implementation , Performance Goals Metrics , Transparency Several , Chair Cathy ,

United States - Healthcare - Rethinking Interchangeability, Top Cases, And Battling Misinformation At FDLI's Annual Conference

Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory. ....

Erika Lietzan , Patrizia Cavazzoni , Procter Gamble Company , Drug Law Institute , European Union , Drug Evaluation , Ninth Circuit , Gamble Company , Fifth Circuit ,

House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines

Agency official also seeks Congress's help with preventing device shortages ....

White House , District Of Columbia , United States , Dan Crenshawr Texas , Joyce Frieden , Peter Marks , Jeffrey Shuren , Patrizia Cavazzoni , Richard Hudson , Supreme Court , House Energy Commerce Health Subcommittee , Radiological Health , House Energy , Commerce Health Subcommittee , Raul Ruiz , John Sarbanes , Drug Evaluation , Biologics Evaluation , Robin Kelly , Dan Crenshaw , Medpage Today ,

A Milestone in Facilitating the Development of Safe and Effective Biosimilars

The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan. ....

Hilary Marston , Patrizia Cavazzoni , Sarah Yim , Drug Administration , Association Of Accessible Medicines , New Drug Office , Therapeutic Biologics , Chief Medical Officer , Drug Evaluation , Biologics Price Competition , Innovation Act , Accessible Medicines , Action Plan , Biosimilars Action Plan ,

FDA Roundup: April 26, 2024

FDA Roundup: April 26, 2024
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