FDA Law Blog

MARCH 16, 2022

is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connect’s Drug Pricing Transparency Congress , which is being held virtually and in-person in Philadelphia on March 28-29, 2022. Hyman, Phelps & McNamara, P.C.

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FDA Law Blog

OCTOBER 4, 2023

However, Judge Newman distinguished Michigan Bell from the present case because the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” See Motion at 11. Order at 22. Order at 24.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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The Clinical Problem Solvers

NOVEMBER 22, 2021

Episode Learning Objectives: After listening to this episode learners will be able to… Understand the historical and present-day role of settler colonialism behind health disparities in Indigenous populations. Do not exclude Indigenous peoples in your research narratives. If you’re going to, acknowledge your limitations.

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FDA Law Blog

JANUARY 18, 2022

This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. Rather, it is meant to present various scenarios related to use of 3D?printed The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices.

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FDA Law Blog

OCTOBER 8, 2023

HPM’s Presentation Deck and recording of the presentation are here, and here (passcode Bv3*o^i5). That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. DEA received a whopping 38,000 (!)

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FDA Law Blog

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. On March 20-21, Counsel John W.M.

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FDA Law Blog

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

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FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. By David B. Clissold & Sara W. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

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FDA Law Blog

DECEMBER 11, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program.

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FDA Law Blog

DECEMBER 9, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program.

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FDA Law Blog

JANUARY 18, 2022

This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. Rather, it is meant to present various scenarios related to use of 3D?printed The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices.

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FDA Law Blog

SEPTEMBER 17, 2023

Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. If FDA is slow in providing that list, it is fine to send a follow-up email requesting a list of FDA attendees in advance of the meeting. Be ready with backup options (e.g.,

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ABIM

MAY 18, 2025

This burden of the disease is being felt by patients and healthcare providers. I now know that the symptom I initially presented with—perianal fistulas—was a hallmark of Crohn’s disease. Worse yet, patients may avoid speaking up, even with their own providers, while suffering silently in pain.

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FDA Law Blog

AUGUST 23, 2021

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. not friends, significant others, or family members of a speaker or invitee).

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BMJ

JULY 17, 2020

As previous research has found, providing factual information helps tremendously in addressing misconceptions and myths about infectious diseases, the latter of which can seriously undermine implementation of preventive measures. 新冠肺炎疫情报道中的信息呈现与媒体表现 [Information presentation and media performance during the COVID-19 outbreak].

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FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. Deb along with fellow panelists Kyle Y.

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FDA Law Blog

MARCH 1, 2023

The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage. In addition to providing some background on QMM, the FDA presented lessons learned from the QMM Program Pilots.

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FDA Law Blog

JULY 6, 2021

Koblitz — FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated New Drug Application (“ANDA”) “in its present form”—is not a final agency action and thereby not subject to challenge in Court. 314.110(c).

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Tiny Physician

FEBRUARY 15, 2022

Incompetent government The doctor-patient ratio of India is one of the worst in the world; we have 1 doctor for 1456 people against the WHO recommendation of 1:1000 [5]. There is only 1 government doctor for a population of 11,000 people and there is only 1 dental surgeon per 175,000 people [6]. What can we do to solve this problem?

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

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GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective. Joe, your thoughts?

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FDA Law Blog

APRIL 22, 2025

By law, DEA must provide you with notice and an opportunity for a hearing before it can take away your registration (or deny your application), so DEA will issue an Order to Show Cause, which explains the legal grounds for revoking or denying a registration and informs you of your right to challenge DEAs decision.

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FDA Law Blog

JANUARY 11, 2024

FDA provided each Boehringer and Pfizer the opportunity to present its interpretation of FIE expiration provisions, but FDA ultimately “decline[d] to adopt either Pfizer’s or BI’s proposed interpretation.” Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.

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FDA Law Blog

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. In this case, the Supreme Court provided greater clarity on how to interpret that requirement. What was SuperValu all about?

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FDA Law Blog

JUNE 8, 2023

The pandemic also deeply impacted how industry and the government conduct their operations. A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

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FDA Law Blog

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

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FDA Law Blog

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. . § The statute does not provide any applicable exception for such a falsity.

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FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. The Guidance provides practical guidelines for both firms and direct accounts. The Guidance emphasizes that firms need to be “recall ready.”

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FDA Law Blog

APRIL 23, 2021

The question presented is whether this statutory language authorizes the Commission to seek, and a court to award, equitable monetary relief such as restitution or disgorgement. FDA through the DOJ could decide to file one or more injunction cases where the government seeks monetary relief from a defendant. 592, 15 U.

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FDA Law Blog

AUGUST 17, 2022

We note, however, that some of the most important clarifications are not codified in the actual rule but are presented in the Preamble; thus, while FDA currently plans to interpret the rule as it states in the Preamble, it is not bound to do so. FYI, FDA does not use the term “regular hearing aids,” but we are for simplicity.)

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FDA Law Blog

JUNE 27, 2024

Coconut Grove had noted “verified” on the prescriptions which DEA found “is not sufficient to identify and resolve any red flags that may be present.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. 21 U.S.C. § 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a),

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Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. ” Abstract/Full Text Copyright © 2025 HealthDay.

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ABIM

JUNE 4, 2025

Dr. McDonald spoke about ABIM’s work engaging early career physicians (those who earned initial certification within the last 10 years), including presentations and listening sessions at recent national meetings. Community Practice in ABIM Governance* Erica N. He suggested a similar approach for APDEM’s annual meeting.

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ABIM

JUNE 24, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles. Advanced Practice Providers in the Hematology-Oncology Workforce* Guinevere Z.

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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. Community Practice in ABIM Governance* Erica N. Visit ABIM’s Openings page for the latest governance openings. Rodriguez, MD , Chair of the Nephrology Board, and John C. Siddharta G.

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ABIM

JUNE 11, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

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