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. Her doctor and several pharmacies turned her down because she was below the recommended age at the time, which was 60. So, in 2016, she celebrated her 60th birthday at her local CVS. Kennedy Jr.,

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FDA Law Blog

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 Blog

SEPTEMBER 15, 2023

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space.

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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. .” And, the U.S. Food and Drug Administration (FDA) warns that they pose similar risks of addiction and life-threatening side effects. Amid a rise in calls to U.S.

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FDA Law Blog

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. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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PEMBlog

JUNE 7, 2023

Government. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what prehospital providers should do to get these agitated children safely to the ED. It is also episode 4 in a 5 episode series focused on agitation in children and adolescents.

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FDA Law Blog

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While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).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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FDA Law Blog

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. By John W.M. Claud & Kalie E. Inspections went down—way down—during the pandemic.

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FDA Law Blog

MARCH 5, 2024

In granting the Government’s summary judgment motion, the court held that AstraZeneca did not have the requisite standing for the APA arguments because it failed to identify a cognizable injury-in-fact that could be redressed by vacatur of the Guidance. Opinion at 17. see also 42 U.S.C. 1320f-1(e)(1)(A).

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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 Blog

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. The memorandum also introduced the Program’s spanking new logo. The Agency invites public comments at IRARebateandNegotiation@cms.hhs.gov.

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FDA Law Blog

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. Gilbert , Gail H. Javitt , Kurt R. Karst , Alan M.

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PEMBlog

MAY 31, 2023

Government. 2023 Mar 21:S1876-2859(23)00091-8. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate pharmacologic management strategies for agitated children. It is also episode 3 in a 5 episode series focused on agitation in children and adolescents.

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Management Patient-Centered Transportation Finance 91

PEMBlog

MAY 17, 2023

Government. Why then do we persist with the “is it medical/organic or psych” question? It is also episode 1 in a 5 episode series focused on agitation in children and adolescents. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

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FDA Law Blog

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. Not every diligence issue is a dealbreaker.

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FDA Law Blog

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. H&P specifically relies on the Supreme Court decision in Jarkesy , as well as the 2023 Supreme Court decision in Axon Enterprise, Inc. By JP Ellison & Anne K. See SEC v Jarkesy , 144 S.

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FDA Law Blog

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 Blog

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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FDA Law Blog

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.

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FDA Law Blog

JANUARY 29, 2023

Evans* — A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification. Legal Assistant/Paralegal

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FDA Law Blog

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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PEMBlog

JUNE 14, 2023

Government. Pediatrics March 2023; 151 (3): e2022057383. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what we should consider when boarding children in the ED for mental health reasons. Coker, Gretchen J. Cutler, Matthew Hall, Rustin B. Morse, Katherine A.

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Mental Health Management Patient-Centered Illness 98

FDA Law Blog

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 Blog

MAY 19, 2025

By Larry K. Houck Last month the U.S. 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 Blog

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 Blog

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 Blog

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. that Congress may not delegate to an agency the authority to arbitrarily set pricing while “barring judicial review of many decisions critical to pricing determinations under the Act.”

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FDA Law Blog

FEBRUARY 2, 2023

While these changes to the IND and the biosimilarity provisions represent real changes to the words governing FDA’s authority under the FD&C Act, we think it is worth asking just how measurable and immediate an impact they will have on day-to-day decision-making of the FDA and its review staff.

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FDA Law Blog

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. Post-market, combination products potentially face the same enforcement scrutiny as single-entity medical devices.

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FDA Law Blog

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. Two 340B covered entities joined the litigation as intervenors arguing to uphold the law. & Mfrs. McClain , No. 22-3675, 2024 U.S. LEXIS 5840 (8th Cir. 2024) at 13 (“Decision”).

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FDA Law Blog

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. The drug was indeed selected on August 29, 2023.

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FDA Law Blog

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. Not eligible. Not eligible.

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FDA Law Blog

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 Blog

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 Blog

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. Over the past few months the Pet Food Institute (PFI) has discussed a new system to federally regulate pet food.

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FDA Law Blog

SEPTEMBER 17, 2023

Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in. During this time, CDRH moved from Webex to Zoom and gained experience with the virtual platform. Having a hard copy of this email may expedite your entry through security checkpoints.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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