Ripped from the Headlines: Hot Topics in Life Sciences 2024
In this on-demand webinar recorded live on November 20, 2024, presenters Kate Klaus and Zuhal Reed from Medmarc’s Risk Management team addressed the key topics in the life sciences industry for the year. The discussion included various updates and changes within the pharmaceutical sector, such as upcoming modifications to over-the-counter cold medications, the FDA's adoption of ISO 13485 standards, and new regulations for drug advertising.
Additionally, the team covered the FDA's final rule regarding laboratory-developed tests (LDTs), the potential challenges associated with its implementation, and the proposed regulations for biosimilars. Finally, they highlighted the difficulties of regulating artificial intelligence (AI) and machine learning technologies.
On-demand Chapters:
00:00 - Intro of Speakers; Medmarc's Kate Klaus, Esq. & Zuhal Reed, Esq.
01:07 - OTC Changes Ahead for Cold Meds
06:28 - FDA's QS Final Rule for Medical Devices
14:06 - Direct-to-Consumer Advertising
24:40 - FDA's Final Rule for Laboratory Developed Tests (LDTs)
30:52 - Laboratory Developed Tests (LDTs): Is that the end of the story?
36:50 - FDA's Proposed Rule for Biosimilars
42:21 - AI and the Impossible Task of Regulating the Hottest Tech
51:00 - Closing
Presenters: Kate Klaus & Zuhal Reed with Medmarc
