What's on the horizon for the life sciences industry? Robin Johnson, PharmD, Gene Therapy Submissions Lead, inSeption Group What unique challenges do gene therapy submissions face compared to ...
FOX 13 Seattle on MSN6h
FDA releases guidance on artificial intelligenceThe FDA is releasing the first-ever guidance on how the pharmaceutical industry can use AI. Nothing to Watch on Hulu? These ...
Of the 1,757 total AI use cases reported by federal agencies last year, 227 of them were listed as safety- or ...
What will shape AI governance? Industry leaders share key insights, highlighting diverse yet interconnected factors driving ...
In this edition of InnovationRx, medical debts will be erased from credit histories, this farm is doubling down on raw milk ...
Shares of Sana Biotechnology Inc. (NASDAQ: SANA) were trading at $4.97, up $3.32, or 201%, on first results from an investigator-sponsored, first-in-human study transplanting UP-421, an allogeneic ...
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback