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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 floats updated orthopedic coatings guidance

"Stay updated on FDA s proposed guidance for orthopedic product coatings. Learn about additional data requirements and potential changes to 510(k) submissions." ....

Draft Guidance , Remarket Application Requirements , Rthopedic Product Coatings , Regulatory Focus , Alcium Phosphate Coating , Coating Process , Terility Considerations , Iocompatibility Considerations , Special Control , Consensus Standards , Da Recognized Version , Public Health , Declaration Of ,

TSCA, FIFRA, TRI Regulation Developments from EPA March 2023

EPA Updates TSCA Inventory, Plans Next Update In Summer 2023. EPA announced that latest TSCA Chemical Substance Inventory is now available on its website. TSCA Inventory is list of all existing chemical substances manufactured, processed, or imported in the United States. ....

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White House Finalizes AI Regulatory Framework and Directs Agencies to Develop Plans for AI Regulation and "Non-Regulation" | Davis Wright Tremaine LLP

Overview
The White House, through its Office of Management and Budget (OMB), has issued final Guidance for Regulation of Artificial Intelligence Applications (Guidance) which establishes a framework for federal agencies to assess potential regulatory and non-regulatory approaches to emerging Artificial Intelligence (AI) issues. Consistent with its initial draft guidance, the final Guidance encourages federal agencies to consider ways to both reduce barriers to the development and adoption of AI and address potential regulation of technologies enabled by AI.
The Guidance reaffirms this Administration s light-touch regulatory framework for AI, while at the same time directing further development of formal plans by regulatory agencies that may be active in this area. Given the impending transition to a new Administration next year, the scope and direction of future agency plans could deviate from the framework in the Guidance. ....

White House , District Of Columbia , United States , Davis Wright Tremaine , Office Of Management , Agency Implementation , Dwt Ai Team , Artificial Intelligence Applications , Artificial Intelligence , Executive Order , Impact Analysis , United State , Specific Policy Guidance , Consensus Standards , வெள்ளை வீடு , மாவட்டம் ஆஃப் கொலம்பியா , ஒன்றுபட்டது மாநிலங்களில் , டேவிஸ் ரைட் திரேமைநே , அலுவலகம் ஆஃப் மேலாண்மை , டுவ்த் ஐ அணி , செயற்கை உளவுத்துறை பயன்பாடுகள் , செயற்கை உளவுத்துறை , நிர்வாகி ஆர்டர் , தாக்கம் பகுப்பாய்வு , ஒன்றுபட்டது நிலை , குறிப்பிட்ட பாலிஸீ வழிகாட்டல் ,

Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway

Center for Devices and Radiological Health
This guidance provides performance criteria for magnetic resonance (MR) receive-only coils in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for MR receive-only coils will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.
Submit Comments ....

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