FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

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.

Manufacturing 59

Manufacturing Specialization Clinic Provider 59

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. Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information.

Management 52

Management Telemedicine Patients Insurance 52

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. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

Referral 59

Referral Relationship Government Healthcare 59

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.

Provider 59

Provider Healthcare Individual IT 59

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

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.

Manufacturing 52

Manufacturing Clinic Provider Medical 52

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.

Insurance 130

Insurance Management Hospital Vaccination 130

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.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

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. §

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

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.)

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45

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.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

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).

Specialization 69

Specialization Manufacturing Electronics PCP 69

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.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

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.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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?

Vaccination 127

Vaccination IT Patient-Centered Patients 127

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.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

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. If significant progress toward MFN is not made, the EO seeks to permit personal importation of less expensive drugs from foreign countries.

Manufacturing 59

Manufacturing IT Individual Provider 59

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.

Manufacturing 59

Manufacturing Specialization IT Provider 59

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).

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. The political battle went into gear on January 28, 2025, with an Executive Order titled Protecting Children from Chemical and Surgical Mutilation. 116(e) (emphasis added).

Manufacturing 59

Manufacturing Provider Medical IT 59