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CONTINUED AGAIN: DEA Announces A Second Extension of its “Temporary Rule” Addressing Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency

FDA Law Blog

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. By Karla L. comments on the two proposed rules.

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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023.

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

FDA Law Blog

1.740), stating that: If the applicant for patent term extension was not the marketing applicant before the regulatory agency, then there must be an agency relationship between the patent owner and the marketing applicant during the regulatory review period. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. Appendix D. Biogen MA Inc.

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PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

So we did a podcast on aging and homelessness with Margot Kushel in 2023. By the time he got into us, the tumor grew, he had experienced, he was experiencing significant pain and so trauma, informed care and building a relationship with him was such a big part of the care. Government is not the 51st state.

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Allowing Patients to Die: Louise Aronson and Bill Andereck

GeriPal

Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. Widera and Smith have no relationships to disclose. Guests Louise Aronson and Bill Andereck have no relationships to disclose.

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Episode 285: Anti-Racism in Medicine Series – Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations

The Clinical Problem Solvers

Gillette” Gillette-Pierce May 2, 2023 Summary: This episode highlights the psychosocial and cultural considerations for providing healthcare to immigrant and refugee populations. April 25, 2023 Show Transcript Download CPSolvers App here RLRCPSOLVERS

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. Second, absent some kind of contractual relationship between a provider and a manufacturer, a provider is generally immune from misbranding if the provider is not also selling a regulated product. Driehaus , 573 U.S. See 21 U.S.C.