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DEA Food and Drug Administration (FDA) Prescription Drugs

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: Rep. McCarthy Ousted as Speaker of the House; CMS Announces Drug Manufacturer Participation in...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Alston & Bird

Health Care Week in Review: Medicaid Managed Care Plans Inquiry Announced

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week In Review: HHS Awards $218 Million in Grant Funding

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Foley & Lardner LLP

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

Gardner Law

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

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Lastly, there are several clinical factors the Agency encourages sponsors to consider. One way psychedelics differ from other drugs is that the use of a traditional placebo as a control may be challenging, as an active drug...more

Holland & Knight LLP

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

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The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

Alston & Bird

Health Care Week in Review: HHS Coverage Flexibilities and MedPAC/MACPAC Reports

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week In Review: COVID-19 PHE Expires, DEA Issues Final Rule

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Lippes Mathias LLP

FDA Regulation of CBD is TBD

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After rounding out 2022 with a series of warning letters to companies selling products containing cannabidiol (“CBD”) the U.S. Food and Drug Administration (“FDA”) began 2023 by issuing a press release announcing its...more

Alston & Bird

Health Care Week in Review: DEA Issues Proposed Rules on Controlled Substances Prescribing via Telemedicine

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

BakerHostetler

FDA Issues Guidance on Clinical Research with Cannabis

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On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more

Goodwin

Five Key Regulatory Considerations for Virtual Ketamine Clinics

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The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more

American Conference Institute (ACI)

[Event] Controlled Substances – Regulation, Litigation, and Enforcement - July 12th - 13th, Washington, DC

The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more

Oberheiden P.C.

Prescription and Medication Counterfeiting Defense

Oberheiden P.C. on

21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more

Mintz - Health Care Viewpoints

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more

K&L Gates LLP

HHS Exemptions for Buprenorphine (but not Methadone) Prescribers

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For the year ending August 2020, provisional data from the Centers for Disease Control and Prevention shows that opioid overdose deaths increased 26.8 percent compared to the previous 12 months, with opioid overdoses...more

Mintz - Health Care Viewpoints

Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids

The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2020

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2020 #1

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Food - Hemp Production Program Comment Period Reopened – The U.S. Department of Agriculture (USDA) is providing an additional 30 days for public comments on the interim final rule that established a domestic hemp production...more

BakerHostetler

FDA Provides Playbook for Developing Cannabis Drugs

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The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

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