FDA Law

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). The government asserted additional allegations that are outside our scope. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. Zarzamora Press Release.

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FDA Law

DECEMBER 7, 2023

Panelists from CPB, FDA, and the Federal Trade Commission (FTC) all amplified the enduring government policy that they expect companies in the food and drug space have robust and legitimate compliance programs. The last panel of Day 1 provided a bookend to the keynote’s clarifications about parallel disclosure.

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Physician's Weekly

JUNE 26, 2025

The 2023 American Academy of Pediatrics (AAP) Clinical Practice Guidelines has a section that discusses different approaches (eg, virtual visits, including allied providers, thinking about community programs, etc.). How can clinicians improve access to childhood obesity interventions? It really does take a village.

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Physician's Weekly

JUNE 24, 2025

has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. The new studies are coming at a fraught political moment. The nation’s health secretary, Robert F. Kennedy Jr.,

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PEMBlog

JUNE 7, 2023

Government. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S.

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Physician's Weekly

JUNE 17, 2025

Tianeptine is sold in a number of countries as a government-approved treatment for depression. Between 2018 and 2023, tianeptine-related calls to U.S. But the FDA has never approved it for any medical condition in the U.S. It cannot legally be sold as a dietary supplement or added to foods or drinks. .”

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FDA Law

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

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FDA Law

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. By Karla L. comments on the two proposed rules.

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FDA Law

MARCH 5, 2024

According to the court, AstraZeneca’s “desire” or even “expectation” to sell its drugs to the Government at the higher prices it once enjoyed does not create a protected property interest.” The court reasoned that no one is entitled to sell to the Government at prices the Government will not agree to pay. Ohio (9 June 2023).

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PEMBlog

MAY 31, 2023

Government. 2023 Mar 21:S1876-2859(23)00091-8. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S.

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Management Patient-Centered Finance Transportation 89

FDA Law

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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My Green Doctor

APRIL 4, 2025

According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% Behavior Change Happens in the Exam Room Unlike government agencies or corporations, healthcare professionals speak directly to individuals in a trusted, one-on-one setting. from 2000 to 2018 among people over 65 years old.

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FDA Law

NOVEMBER 7, 2022

Refunds will still be owed for quarters beginning with 1Q 2023, and CMS will still send annual reports to manufacturers containing the number of discarded units and the refunds owed for four quarters. The requirement to use a JZ modifier where there were no discarded amounts has been delayed for six months until July 1, 2023.

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PEMBlog

MAY 17, 2023

Government. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S.

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FDA Law

JANUARY 29, 2023

Mr. Farquhar will be presenting the results of research on FDA’s inspection database which he and HPM Legal Assistant Aisha Evans conducted. The chart below shows the number of inspections per fiscal year (FY) (which runs from October 1 through September 30). FDA, Inspections Database (last visited Jan. Legal Assistant/Paralegal

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FDA Law

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. CDER and CBER CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023.

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PEMBlog

JUNE 14, 2023

Government. Pediatrics March 2023; 151 (3): e2022057383. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources. Coker, Gretchen J. Cutler, Matthew Hall, Rustin B. Morse, Katherine A. Nash, Kavita Parikh, Bonnie T. 10.1542/peds.2022-057383

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FDA Law

JANUARY 8, 2024

If this all holds true, it will follow the upward trend of the 2023 year in deals. Moreover, it requires not only an understanding of what the laws say, but how what the government would be expected to do in the future based on the regulatory compliance history.

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FDA Law

JULY 17, 2022

On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund. Refunds will be payable for single-dose container drugs beginning on January 1, 2023. Of necessity, the October 1, 2023 report will contain only claims for 1Q 2023.

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FDA Law

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. This all sounds complicated, I know.

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FDA Law

JUNE 3, 2024

Wasserstein — Today’s email brings an interesting, and somewhat confusing settlement of what should have been an ordinary antikickback statute case , and may bring about a clash between what many companies do and what the government may be objecting to. In 2023, DePuy paid $9.75 The facts of the settlement are rather simple.

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FDA Law

MARCH 3, 2024

The LDT rule has moved forward with astonishing speed, advancing from the release of the proposed rule on October 3, 2023 to OMB in less than five months. Given that Congress struggles to keep the government funded, it is far-fetched now to expect Congress to enact this complex legislation – especially since it has repeatedly failed to do so.

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FDA Law

OCTOBER 7, 2024

H&P specifically relies on the Supreme Court decision in Jarkesy , as well as the 2023 Supreme Court decision in Axon Enterprise, Inc. 175 (2023) (holding that district courts have jurisdiction to hear constitutional challenges to agency authority to adjudicate enforcement actions). Constitution. FTC , 598 U.S.

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FDA Law

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law

MARCH 29, 2024

In 2022, the Government Accountability Office reported that FDA needed to improve its foreign inspection program. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022. But gaps still remain. The vast majority are for drugs.

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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. § 812 (b)(1).

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FDA Law

FEBRUARY 11, 2025

Gaulkin Drug manufacturers wont be receiving their first invoices for Medicare Part B and Part D inflation rebates until later this year, but rebates have been accruing since first quarter 2023 for Part B rebates and October 2022 for Part D rebates.

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FDA Law

MAY 19, 2025

Press Release , Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S. Attorneys Office, Northern District of Illinois, April 21, 2025.

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FDA Law

FEBRUARY 27, 2023

In an erratum filed to the deposition of an official previously self-identified as the Chief FOIA Officer, the government stated that the individual was in fact, not the Chief FOIA Officer for DEA but Chief of the FOIA/PA Unit at DEA. Aims Institute, PLLC, v. Merrick Garland, et. al , Case No. 4:2022-cv-02396 S.D.

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FDA Law

JANUARY 18, 2023

Businesses that reasonably believe they qualify for the exception will be asked to submit their data in the summer of 2023. CMS is proposing that all data submissions will be due by October 2, 2023. CMS plans to collect information about how manufacturers aggregate as single employers to evaluate them for the exception.

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FDA Law

MAY 30, 2024

District Court and won, prompting a government appeal to the D.C. Six states have enacted contract pharmacy protections into law: Kansas , Maryland , Mississippi , and West Virginia in 2024, Louisiana in 2023, and Arkansas in 2021. We have blogged about this controversy in previous posts (see e.g., here and here ).

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FDA Law

JUNE 12, 2023

PFI’s frustration and concern around the current regulatory process overseen by state governments was discussed during the Petfood Forum 2023 convention in Kansas City, MO. PFI has noted that it is not feasible to develop and label products for an individual state.

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FDA Law

JUNE 26, 2023

September 1, 2023 will be the selection date for the 10 drugs that will be subject to “maximum fair price” ceilings under Medicare Part D starting in 2026. Chamber of Commerce makes all the arguments that the other plaintiffs have made, and also alleges that Congress has no power to levy the excise tax because it “compels” commerce.

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FDA Law

JANUARY 5, 2023

Thus, cybersecurity is tightly intertwined with safety and effectiveness, and government regulators seem willing to invest in the resources to detect cybersecurity problems that affect the regulatory landscape. More updates will follow here as trends develop in 2023.

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FDA Law

MARCH 24, 2024

The federal government has long maintained that state law offers an additional, and important, layer of consumer protection that complements federal regulation. The court also noted that the practice of pharmacy is an area traditionally left to state regulation. As such, the court held that FDCA does not preempt Act 1103.

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FDA Law

NOVEMBER 15, 2022

Any application from a State or Federal Government entity. The small business fees for FY 2023 can be found here. If you would like to request for FY 2023 status, you can submit an application through September 30, 2023. Exempt from any fee unless the device is to be distributed commercially.

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FDA Law

FEBRUARY 2, 2023

More recently still, FDA requested $5 million in its FY 2023 budget request to support the New Alternatives Method Program to “replace, reduce and refine animal testing (the 3Rs), and improve predictivity of nonclinical testing.” FDORA § 3209(b).

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