FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Physician's Weekly

JUNE 19, 2025

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting. This is the kind of information we all need, all deserve. Claire: And it was.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

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FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

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GeriPal

MARCH 24, 2022

Alex: We are delighted to welcome to the GeriPal podcast, Susan Hickman, who is professor at the Indiana University schools of nursing and medicine, and is director of the IU Center for Aging Research at the Regenstrief Institute. And I don’t think necessarily, that appointment needs to be a medicalized process.

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Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. This information has and is subject to change based on this evolving situation.

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FDA Law Blog

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. Currently Accepted Medical Use in Treatment in the U.S. 21 U.S.C. § 21 U.S.C. §

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GeriPal

DECEMBER 7, 2023

Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. I mean, many people in their mid to older years are on certain medications. I look forward to our conversation.

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GeriPal

OCTOBER 31, 2024

Alex 00:23 And we’re delighted to welcome Peter Chin-Hong, who is an infectious disease physician and medical educator, professor at UCSF and associate dean for regional campuses. And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath.

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FDA Law Blog

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. In contrast, AMP and ACLA both asserted that the rule would harm medical care. The process for gaining this alignment is through the pre-submission program.

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FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. The Medical Procedure Periodic colon cancer screening is recommended for people at average risk starting at age 45 and continuing until age 75, according to the U.S. Then the bill came.

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