FDA Law

FEBRUARY 18, 2025

The discussion of the Agencys expectations of the form and substance of expert witness testimony is a must-read for entities or individuals facing a DEA order to show cause hearing. Notably, this discussion does not cite any prior Agency precedent governing expert testimony standards. In Neumanns Pharmacy, LLC , 90 Fed.

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FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R.

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FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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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. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Referral Relationship Government Healthcare 59

FDA Law

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. Because the Government also failed to provide the Court a written certification in order to comply with Fed. 21 U.S.C. §

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FDA Law

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §

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FDA Law

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S.

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Government Provider Community Individual 59

FDA Law

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. UNDERSTAND the importance of cGMPs to the post-approval regulatory process.

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FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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FDA Law

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations. Gibbs (Hall of Fame), John A.

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Government Provider Medical Management 40

FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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Lab Testing Referral Individual Patient-Centered 40

FDA Law

JUNE 27, 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. By Larry K. 21 U.S.C. §

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FDA Law

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. This program is modeled after a similar program in place for medical devices, the formal standards and conformity assessment program (S-CAP).

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Provider Screening IT Government 59

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting.

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ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. The group discussed policy shifts and potential implications for graduate medical education and health equity. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*. The following is a summary of the spring meeting.

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The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Adopting this worldview removes any obligation to remedy the consequences of segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. Episode Takeaways: 1.

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FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

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FDA Law

NOVEMBER 18, 2021

The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., A follow up laboratory?run run molecular diagnostic (RT?PCR) PCR) test is considered the gold standard for actual diagnosis.

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Screening Healthcare Manufacturing IT 98

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). It authorized FDA oversight over mammography facilities.

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Healthcare Diagnosis Provider Individual 59

FDA Law

APRIL 8, 2024

the focus of the paper turns back to “drug shortages” generally, but HHS acknowledges that “shortages of medical devices have also been an issue for many decades.” HHS suggests that its proposed HRSP “could be expanded to the outpatient setting or to include medical devices.” What about government factors that cause drug shortages?

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Supply Chain Manufacturing Government Hospital 59

FDA Law

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Cocktail Medications. Gulf Med Pharmacy at 72,695. at 72,730.

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IT Insurance Government Patients 40

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). What’s up with Medical aid in dying in Canada? Eric: So again, the topic is going to be medical aid in dying in Canada. Four percent. Transcript Eric: Welcome to the GeriPal Podcast. This is Eric Widera.

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Illness IT Medical Provider 144

FDA Law

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Best Price Stacking We previously blogged about the 4 th Circuit Court of Appeals decision in United States Ex Rel. Sheldon, v.

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GeriPal

MARCH 16, 2023

And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. I was like, I’m fascinated when I read medical books and they’re quoting patients these long paragraphs. I like crafting sentences, I like thinking through things in the way I can. Eric: Yeah.

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FDA Law

FEBRUARY 11, 2024

We blogged on the December 5, 2023, letter from six Democratic governors to President Biden). 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.

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Medical Healthcare Professional Community IT 59

FDA Law

NOVEMBER 18, 2024

Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023. Wise government officials will modulate their views as they learn new facts. To some degree.

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FDA Law

MAY 26, 2025

Even if otherwise truthful, the promotion of off-label uses of hormones-including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses-run afoul of the FDAs prohibitions on misbranding and mislabeling. Driehaus , 573 U.S. 149, 158 (2014). 116(e) (emphasis added).

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