FDA Law

FEBRUARY 26, 2024

(HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, in San Francisco, California. More notably, Ms.

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FDA Law

OCTOBER 8, 2023

Next, on May 9, 2023 DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), issued the First Temporary Rule , which extended the full set of telemedicine flexibilities regarding the prescribing of controlled medications through November 11, 2023. 69,879, 69,880 (Oct. 10, 2023) (emphasis added).

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Physician's Weekly

JUNE 24, 2025

Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. Kennedy Jr.,

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ABIM

APRIL 24, 2025

Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA. Thousands of activities are eligible for both MOC and CME via a collaboration with the Accreditation Council for Continuing Medical Education at cmepassport.org.

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FDA Law

MARCH 3, 2024

3558 ) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act?

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FDA Law

MAY 15, 2024

On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests ( LDTs ). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring significant operational changes and posing strategic challenges for many LDTs.

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FDA Law

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. (HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference.

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FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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FDA Law

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. 2024) , which affirmed Marchettis conviction for receiving illegal kickbacks but determined that most of his actions did not violate the AKS.

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FDA Law

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J.

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FDA Law

MARCH 24, 2024

On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. 22-3675, 2024 U.S. 2024) at 13 (“Decision”). The federal government has long maintained that state law offers an additional, and important, layer of consumer protection that complements federal regulation. & Mfrs. McClain , No. LEXIS 5840 (8th Cir.

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FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance.

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FDA Law

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). Alternating Between Cash and Insurance According to the government’s expert, patients paying for prescriptions with insurance and for others with cash is a red flag for those paid with cash. paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W.

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ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N.

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ABIM

JUNE 11, 2025

This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N.

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Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. But technical limitations have made it hard to understand how neurons in this area form functional circuits."

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FDA Law

DECEMBER 21, 2023

Both are celebrating their 75th anniversaries in 2024. 2024 brings a host of Hyman, Phelps & McNamara, P.C. 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”) In other exciting news — in 2024 FDLI will be getting a make-over! What do Gene Autry’s Rudolph the Red-Nosed Reindeer and FDLI have in common?

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Community Practice in ABIM Governance* Erica N.

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ABIM

JUNE 24, 2025

The group discussed policy shifts and potential implications for graduate medical education and health equity. Dr. McDonald acknowledged that recent executive orders have emphasized more competition in medical and legal education accreditation, but reaffirmed ABIM’s commitment to evidence-based practice and health equity.

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FDA Law

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Although bias may be difficult to eliminate completely, FDA recommends that manufacturers, as a starting point, ensure that the test data sufficiently represents the intended use (target) population of a medical device. By Adrienne R.

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Physician's Weekly

JUNE 23, 2025

Residents of East Palestine, Ohio, where the derailment occurred, have pressed the government to do more to answer questions about the mental and physical health effects of the disaster — from post-traumatic stress to cancer. In 2024, the NIH funded six short-term research projects totaling over $1 million.

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FDA Law

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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FDA Law

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The final rule will be effective on September 10, 2024.

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FDA Law

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

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GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. ABIM MOC credit will be offered to subscribers in November, 2024. What’s up with Medical aid in dying in Canada?

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FDA Law

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. By Karla L. The federal telemedicine flexibilities (i.e.,

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Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

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GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. But one of the things I worry about, when we really know medically where this case is going and we find, how many times has this happened?

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GeriPal

APRIL 18, 2024

And I wonder, now, was this 2024 version sort of a redo? Then, it was like, well, it does as well as, and now, better than humans passing the medical boards, passing the law boards, doing great on the SAT, all that stuff. And the first one was with Zeke Emanuel. Bob: Yeah, but you can imagine- Alex: I wish, but I worry I will not.

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Maine Academy of Family Physicians

JUNE 21, 2024

Pat Connolly reported on the 2024 Maine Legislative Session: It was a short but busy session in Augusta this year. Please consider getting involved here in Maine - the Maine Medical Association & the Maine Osteopathic Association have a joint Legislative Committee that meets weekly during the session (usually January - May).

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FDA Law

FEBRUARY 11, 2024

The former officials implore following the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and the rescheduling impact on prosecuting drug trafficking organizations. and lacks an acceptable level of safety for use even under medical supervision. In other words, no rescheduling.

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Medical Xpress

JUNE 7, 2025

The company is working with governments and health groups in the U.K. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad. © 2025 HealthDay.

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Physician's Weekly

JULY 2, 2025

I think dengue is here with us to stay,” said infectious disease specialist Michael Ben-Aderet, associate medical director of hospital epidemiology at Cedars-Sinai in Los Angeles, about dengue becoming a new normal in the U.S. happen in Puerto Rico, which saw a sharp increase in 2024 , triggering a local public health emergency.

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GeriPal

DECEMBER 21, 2023

But for other- Diane: And it’s on the medical side. Just to let you know, Eric, we have to give the credit to our federal government. So if you can share this early, January 30th, 2024, you can apply as two things, as an established program like us, UCLA, UCSF, or a new program. This is Eric Widera. Diane: Yeah.

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GeriPal

AUGUST 22, 2024

There’s disagreement within, some medical associations are against this. These kinds of questions are coming up for us all the time with advances in medical technology. ABIM MOC credit will be offered to subscribers in November, 2024. So there are people who are very concerned about this. The post What is Death?

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Physician's Weekly

JUNE 12, 2025

In a 2024 report covering the years 2022, 2023, and 2024, Medicaid’s parent agency — the Centers for Medicare & Medicaid Services — said the rate was about 5.1%. Other experts told PolitiFact that the actual numbers could be higher than what the federal government reports, although not as high as Paragon’s estimate.

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Physician's Weekly

JULY 2, 2025

For more than a decade, a small team of people at the Centers for Disease Control and Prevention worked to do just that, issuing national guidelines for clinicians on how to prescribe contraception safely for millions of women with underlying medical conditions — including heart disease, lupus, sickle cell disease, and obesity.

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