FDA Law

DECEMBER 7, 2023

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. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements.

Consulting 52

Consulting Provider Manufacturing Specialization 52

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While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

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.

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

Physician's Weekly

JUNE 17, 2025

Tianeptine is sold in a number of countries as a government-approved treatment for depression. It claimed to provide “an unparalleled solution to cravings for opiates.” 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.

Medical 52

Medical IT Hospital Government 52

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.

Telemedicine 64

Telemedicine Relationship IT Mental Health 64

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. In addition, other law firms retain HPM to provide targeted expertise in food and drug law to assist their clients.

Government 40

Government Provider Medical Individual 40

FDA Law

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. Order at 24.

Provider 59

Provider Manufacturing IT Government 59

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.

Manufacturing 59

Manufacturing Government Provider 59

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.

Provider 59

Provider IT Manufacturing Complication 59

FDA Law

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.

Manufacturing 52

Manufacturing Utilities Government Provider 52

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.

Management 45

Management Manufacturing Supply Chain Provider 45

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.

Relationship 53

Relationship Government Screening Medical 53

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. It remains to be seen whether FDA’s hasty finalization of the rule will provide fodder for APA challenges for failing to adequately address substantive comments.

Government 64

Government IT Management Provider 64

FDA Law

MAY 19, 2025

Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents (MMEs). Attorneys Office, Northern District of Illinois, April 21, 2025. 81, 89, 251.

Individual 64

Individual Patients Provider Medical 64

FDA Law

JANUARY 18, 2023

Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance. Businesses that reasonably believe they qualify for the exception will be asked to submit their data in the summer of 2023.

IT 59

IT Manufacturing Provider Government 59

FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Patient-Centered 59

Patient-Centered Manufacturing Provider Telehealth 59

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.

Electronics 59

Electronics IT Government Clinic 59

FDA Law

NOVEMBER 15, 2022

In this blog post, we provide a primer on user fees and the Small Business Program. These fees supplement the annual funding Congress provides for FDA. While the fees provide funding for a review, meeting the timeline 100% is not guaranteed and the performance goals do account for this potential. Exemptions or Waivers.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law

MARCH 24, 2024

The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract pharmacies. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.

Manufacturing 59

Manufacturing Government IT Provider 59

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).

Government 59

Government Medical IT Manufacturing 59

FDA Law

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.,

Screening 59

Screening Transportation Provider Electronics 59

FDA Law

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.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

Provider 59

Provider Screening IT Government 59

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. AFIA highlighted the impact the new framework could have for ingredient suppliers that provide products for all animals, including livestock, dogs, and cats.

Individual 45

Individual Manufacturing Government Illness 45

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).

Clinic 64

Clinic IT Utilities Government 64

FDA Law

AUGUST 17, 2022

This is important because self-fitting hearing aids require the submission and clearance of a 510(k) while regular OTC hearing aids do not, which provides incentive for manufacturers to self-classify their hearing aid products as regular OTC rather than self-fitting. (FYI, The preemption provisions, for example, have not changed.

Provider 40

Provider Manufacturing IT Government 40

FDA Law

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. § 21 U.S.C. §

Insurance 52

Insurance Patients Utilities Chronic Condition 52

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.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The content is provided for information purposes only. But technical limitations have made it hard to understand how neurons in this area form functional circuits." Your feedback is important to us.

Provider 109

Provider Medical Complication Diabetes 109

FDA Law

MARCH 13, 2024

10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. The PTE application paragraph (C) on page 4 indicates that EPKINLY® (epcoritamab-bysp) received approval for commercial marketing or use on May 19, 2023. 10,968,453 (November 29, 2023) Pursuant to 37 C.F.R. Appendix D.

Relationship 59

Relationship Provider IT Government 59

FDA Law

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. surgical robots, MRIs)?

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction. By Philip Won & Lisa M. Emphasis added.)

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

NOVEMBER 21, 2024

DEA notes in the Federal Register notice that it received over 38,000 comments to its 2023 proposed rules (35,454 for the general telemedicine flexibilities proposed rule and 2,915 for the buprenorphine telemedicine flexibilities proposed rule), and held two days of public listening sessions addressing industry comments.

Telemedicine 52

Telemedicine Provider Medical Patients 52

GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. She happened to focus on some specific for-profit hospice providers. JAMA Health Forum.

IT 113

IT Provider Patients Families 113

FDA Law

NOVEMBER 16, 2021

The effective date of the amendments had already been delayed until January 1, 2023 pursuant to court orders in a lawsuit brought by the PBM industry association. Medicare Part B reimburses providers for quantities of drugs packaged in single-use containers that are left over after administration and discarded.

Manufacturing 40

Manufacturing Utilities Management Provider 40

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. They can’t believe it, but we come back again and again and again gently to provide that support. We just hired a nurse.

Healthcare 100

Healthcare IT Community Illness 100

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. The preamble provides an example of reporting an incorrect baseline AMP, which reduces the unit rebate amount. Sheldon, v.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

SEPTEMBER 5, 2024

Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. And it’s not the same, but it does provide information. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. It happened to my mother. Louise, what happened to your mom?

Patients 98

Patients IT Patient-Centered Hospital 98