FDA Law Blog

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. Applying AI models to review large amounts of data from multiple manufacturers could help FDA identify early signals related to product quality and patient safety. By Adrienne R.

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FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. By Steven J. Gonzalez & Allyson B.

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FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. By Steven J. Gonzalez & Lisa M.

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Physician's Practice

JUNE 9, 2025

of Roetzel & Andress June 9, 2025 By Austin Littrell Fact checked by Keith A. a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Austin Littrell June 2nd 2025 Podcast Tom Price, M.D., 68: Hidden risks of prescribing GLP-1 drugs with Ericka L.

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FDA Law Blog

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And it is exactly that!

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FDA Law Blog

JANUARY 5, 2025

In discussing these revisions, FDA clarified that an ACNU failure must be reported even if the failure does not cause or lead to inappropriate medication use or consumer harm. The final rule becomes effective on January 27, 2025. The third was the postmarketing requirement for reporting an ACNU failure.

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FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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FDA Law Blog

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026. Notable Dates and Timelines – New MAPP published, by Dec.

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Physician's Weekly

JUNE 18, 2025

WEDNESDAY, June 18, 2025 (HealthDay News) — On Tuesday, the U.S. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a one-day tumor board-style discussion. said in a statement.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

As the 2025 legislative session swings into full gear, the Alabama Academy of Family Physicians (AAFP) has set its sights on a cadre of pivotal bills set to shape the healthcare landscape for years to come. Chip Brown, HB 2 proposes a change to existing law regarding the consent process for medical procedures involving minors.

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FDA Law Blog

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. For non-AI-enabled devices, the early feasibility research may not directly affect the development process, i.e., the final, finished device can be fully developed, transferred to a controlled manufacturing environment, and tested under a design controls process.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

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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. While that observation is intended as praise for the TAP Pilot, it can be considered a sad commentary on the general state of manufacturer-CDRH interactions.)

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FDA Law Blog

FEBRUARY 4, 2025

Koblitz Last December, Congress narrowly avoided a shutdown by significantly paring down the originally proposed 2025 Appropriations bill, slashing away hundreds of programs and laws. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs.

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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. cases in 2024-2025, H5N1 disease in humans had a high mortality rate of up to 50%. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

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FDA Law Blog

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. 23,711 (June 4, 2025). We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 23,483 (June 3, 2025).

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D.

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Doctors for America

MAY 15, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 15, 2025 Doctors for America’s FDA Task Force Dismayed by Kennedy Testimony WASHINGTON, D.C. DFA is an organization of over 27,000 physician and medical student advocates in all 50 states, representing all areas of specialization.

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FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

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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 then, of course, other treatments and other sort of medications and such came out. Year four, year four of COVID What are you hoping in 2025, Lona?

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FDA Law Blog

JUNE 1, 2025

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Its unclear whether there are truly regulatory gaps that require new legislation.

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FDA Law Blog

MAY 8, 2025

Claud On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. Walsh & Esther Petrikovsky & John W.M. is safe, legitimate, and honestly made.

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FDA Law Blog

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) it is illegal to import.

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FDA Law Blog

MAY 23, 2025

The RFI reinforces Trumps January 31, 2025 executive order indicating that for every new regulation introduced, at least ten existing regulations must be eliminated (the 10for-1 Rule). The RFI is open through July 14, 2025. The Announcement raises several questions and issues for the device industry. Deregulation Efforts.

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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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FDA Law Blog

MAY 26, 2025

The political battle went into gear on January 28, 2025, with an Executive Order titled Protecting Children from Chemical and Surgical Mutilation. The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. FGM is defined as any procedure performed for non-medical reasons. 116(e) (emphasis added).

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