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Department of Justice (DOJ) Food and Drug Administration (FDA)

Holland & Knight LLP

What's Next for the Regulatory Landscape Post-Chevron?

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For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more

Gardner Law

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

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Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Akin Gump Strauss Hauer & Feld LLP

The Top 10 Takeaways for Businesses from the Supreme Court’s Three Big Administrative Law Decisions in 2024

Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 30, 2024)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences and Health Care Companies Under the Competition Microscope: New Cross-Government Initiatives Seek to Expose...

U.S. antitrust enforcers launched a flurry of initiatives in the first half of 2024 to identify and prevent antitrust and other violations in life sciences and health care. Among these are two cross-agency Requests for...more

Troutman Pepper

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Greenberg Glusker LLP

Cannabis Reclassification: Timeline and Impact

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The federal government has started to reclassify cannabis. When, and if, that reclassification is finalized, licensed cannabis businesses should see dramatically higher after-tax income and access to services from credit card...more

Holland & Knight LLP

Holland & Knight Health Dose: June 11, 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. This week's topics include:...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more

Greenbaum, Rowe, Smith & Davis LLP

Will Rescheduling Cannabis Open the Industry to Increased Financing, Real Estate and Banking Opportunities?

On May 16, 2024, the U.S. Department of Justice (DOJ) issued its proposed rules to transfer cannabis from Schedule I of the Controlled Substances Act (CSA) to Schedule III of the CSA. The DOJ’s proposal follows the U.S....more

Akin Gump Strauss Hauer & Feld LLP

High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more

Quarles & Brady LLP

DEA Publishes Notice of Proposed Rulemaking to Reschedule Marijuana from Schedule I to Schedule III

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The United States Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking to reschedule marijuana from schedule I of the Federal Controlled Substance Act (“CSA”) to schedule III. As a reminder,...more

Jackson Lewis P.C.

Department of Justice Publishes Notice of Proposed Rulemaking to Reschedule Marijuana to Schedule III

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The Department of Justice (DOJ) published a Notice of Proposed Rulemaking to reschedule marijuana from Schedule I to Schedule III of the federal Controlled Substances Act (CSA) in the Federal Register on May 21, 2024. If the...more

McGlinchey Stafford

Rescheduling Marijuana FAQs: How Do I Submit Comments on DEA’s Proposed Rules?

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On May 16, 2024, the U.S. Drug Enforcement Administration (DEA) released the proposed rule (Proposed Rule) to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA). The Office of Legal...more

Holland & Knight LLP

Holland & Knight Health Dose: May 14, 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

Fox Rothschild LLP

U.S. Justice Department Proposes Loosening Restrictions on Marijuana: What's Next

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As anticipated, U.S. Attorney General Merrick Garland has submitted to the Federal Register a notice of proposed rulemaking to consider moving marijuana from a Schedule I to a Schedule III drug under the Controlled Substances...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

ArentFox Schiff

Investigations Newsletter: DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme

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DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme - On April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and...more

Amundsen Davis LLC

A Major Step Towards Reform: The DEA Recommends Rescheduling Cannabis

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In a recent historic announcement, the U.S. Drug Enforcement Administration has determined that cannabis, which is currently categorized as a Schedule I drug under the Controlled Substances Act (CSA), should be rescheduled to...more

Vicente LLP

4 Major Implications of Cannabis Moving to Schedule III

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After 50 years of being on the most restrictive schedule alongside drugs like heroin and PCP, the DEA will move to reschedule marijuana in Schedule III, where the plant’s medical benefits will finally be recognized by the...more

Proskauer - Health Care Law Brief

Public Portal to Promote Healthy Competition

Past long-standing chair of Proskauer’s Health Care Department, Ed Kornreich is a recognized authority on the legal, regulatory and business issues related to health care… Past long-standing chair of Proskauer’s Health Care...more

Oberheiden P.C.

A 4-Point Guide for Pharmaceutical Whistleblowers

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There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

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