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FDA increasing efforts to support CTGT product development | Hogan Lovells

FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in. ....

Nicole Verdun , Office Of Therapeutic Products , Platform Technology Designation , Drug Law Institute , Platform Technology Designation Programs , Trials Advancing Rare , Consensus Standards , Century Cures Act , Technology Designation , Therapeutic Products , Split Real Time Application Review , Rare Disease Endpoint Advancement ,

FDA Draft Guidance On "Rare Diseases Considerations For The Development Of Drugs And Biological Products"

FDA Draft Guidance On "Rare Diseases Considerations For The Development Of Drugs And Biological Products"
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United States , Raj Bandaru , Natural History Studies For Drug Development , Considerations For The Development Of Drugs , Accenture Applied Life Science Solutions , National Organization For Rare Disorders , Drug Administration , Information Center , Associate Director , Accenture Applied Life Science , Biological Products , National Organization , Rare Disorders , Rare Diseases , Natural History Studies , Drug Development , Fast Track Designation , Breakthrough Designation , Orphan Drug Designation , Rare Pediatric Designation , Pediatric Rare Voucher , Orphan Drug Exclusivity , Path Innovation Meetings , Initial Targeted Engagement , Regulatory Advice , Accelerating Rare Disease Cures ,

Searching for Surrogates: The Effort to Speed Up Drug Trials

Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging. ....

United States , National Institutes Of Health , San Francisco , Amaru Kishan , Hiddol Heerspink , Vincent Planche , Juliaa Beaver , Carol Taylor Burds , Los Angeles , Karin Hoelzer , Fabio Conforti , Richard Pazdur , Anushka Walia , Emersony Chen , Ginny Beakes , Fady Ghali , Rare Diseases Information Center , Pilot Meeting Program , University Of Washington School Medicine , Oncology Center , University Of California , Oregon Health Science University In Portland , International Classification Of Disease , Drug Administration , European Renal Association , University Medical Center Groningen ,

Searching for Surrogates: The Effort to Speed Up Drug Trials

Identifying surrogate endpoints for use in clinical trials that strongly predict clinical outcomes such as improved survival and quality of life is challenging. ....

United States , National Institutes Of Health , San Francisco , Fabio Conforti , Vincent Planche , Fady Ghali , Karin Hoelzer , Ginny Beakes , Carol Taylor Burds , Amaru Kishan , Richard Pazdur , Hiddol Heerspink , Anushka Walia , Los Angeles , Emersony Chen , Juliaa Beaver , University Of California , Drug Administration , Pilot Meeting Program , European Institute Of Oncology , International Classification Of Disease , European Renal Association , University Of Washington School Medicine , Oncology Center , Amgen Inc , University Medical Center Groningen ,

Accelerating Rare disease Cures (ARC) Program Emerges as a Conduit for Empowering Rare Disease Stakeholders

The ARC Program strives to increase the number of treatments by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging with patients and their advocates, and other rare disease stakeholders. ....

Kerry Jo Lee , Office Of Translational Sciences , Office Of New Drugs , Regulatory Aspects Of Rare Disease Drug Development , Division Of Rare Diseases , Rare Disease Drug Developers , Rare Diseases Team , Office Of Communications , Office Of The Center , Rare Neurodegenerative Disease Grant Program , Drug Development Program , Drug Administration Center , Oncology Center , Program Future Outreach , Radiological Health , Pilot Program , Office Of Rare Diseases , Associate Director , Rare Diseases , Medical Devices , Reproductive Medicine , New Drugs , Drug Evaluation , Drug Administration , Accelerating Rare , Center Director ,