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Classification Food and Drug Administration (FDA)

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

DLA Piper

HHS to DEA: Marijuana Should Be Schedule III – What This Means for The Cannabis Industry

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In a non-public letter sent earlier last week, the US Department of Health and Human Services (HHS) recommended to the US Drug Enforcement Administration (DEA) that marijuana be re-classified under the Controlled Substances...more

Mandelbaum Barrett PC

Reclassifying Cannabis as Schedule III: Unpacking the Impact on Taxation, Medical Research, and Social Justice

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On April 30, 2024, the Associated Press reported a significant development in cannabis policy:  the U.S. Drug Enforcement Administration (“DEA”) is recommending reclassifying cannabis from Schedule I to Schedule III. This...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

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more

Clark Hill PLC

Cannabis Reclassification: Litigation Impact

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In a historic move, the DEA accepted the US Department of Health and Human Services’ recommendation to reclassify marijuana from Schedule I to a Schedule III controlled substance, arguably the most significant change to...more

Clark Hill PLC

The Good, The Bad and The Ugly: DEA Rescheduling Marijuana to Schedule III

Clark Hill PLC on

On April 30, the U.S. Drug Enforcement Administration issued a proposed rule to move marijuana from the Schedule I class to Schedule III. If approved this will be the most significant change in federal marijuana law since...more

Hinshaw & Culbertson LLP

DEA's Decision to Reschedule Marijuana Represents a Massive Shift in U.S. Drug Policy, But Challenges for Cannabis Industry Remain

Earlier this week, we learned that the United States Drug Enforcement Administration (DEA) will likely reclassify marijuana under federal law from Schedule I to Schedule III of the Controlled Substances Act (CSA) based upon...more

Woods Rogers

DEA’s Seismic Move to Reschedule Cannabis

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On Tuesday, April 30, the Associated Press reported that the Drug Enforcement Administration (DEA), will move to reclassify marijuana from a Schedule I drug to a Schedule III drug.  DEA’s move comes several months after the...more

Dickinson Wright

Look Before You Leap – Early Determination of Product Classification and Regulatory Pathway for FDA-Regulated Products

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Originally published in Healthcare Michigan, Volume 41,  No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more

Venable LLP

Marketing FDA-Regulated Products: An Excerpt from the Advertising Law Tool Kit

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The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more

The Rodman Law Group, LLC

DEA Rejects Psilocybin Rescheduling Petition

In December of 2023, Dr. Sunil Aggarwal of Advanced Integrative Medical Science Institute, filed a petition with the Ninth Circuit Court requesting a new order requiring the Drug Enforcement Administration (“DEA”) to refer...more

Neal, Gerber & Eisenberg LLP

Client Alert: HHS Recommends Rescheduling Marijuana to Schedule III: Implications and Uncertainties for the Industry

Marijuana has long been classified as a Schedule I controlled substance under the Controlled Substances Act of 1970 (the “CSA”), which is defined as a substance with no accepted medical use and a high potential for abuse,...more

McAfee & Taft

Unpacking possible change to marijuana classification

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You may have heard that the federal government may downgrade marijuana from a “Schedule I” to “Schedule III” drug, but do you know the implications of such a change? In October 2022, President Biden issued an executive order...more

McAfee & Taft

Possible downgrading of marijuana to Schedule III drug carries with it significant implications

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If the U.S. Department of Health and Human Services’ recent recommendation to reclassify marijuana as a Schedule III drug is adopted, expect far-reaching consequences. In October 2022, President Biden issued an executive...more

Sheppard Mullin Richter & Hampton LLP

Reclassifying Cannabis as a Schedule III Substance – Will the DEA Agree?

On August 29, 2023, less than one year after President Biden’s directive to federal officials, including the U.S. Department of Health and Human Services (“HHS”) and the U.S. Attorney general, to conduct a review of cannabis’...more

Vicente LLP

A Wake-up Call from Down Under: Australia's Therapeutic Goods Administration Reschedules Psilocybin and MDMA

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As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug...more

Butler Snow LLP

Can What the Supreme Court Said About Device Clearance in Lohr, a “Derelict on the Waters of the Law,” Finally Be Sunk?[1]

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Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more

MoFo Life Sciences

De Novo Classification Final Rule To Take Effect Next Year

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On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule, Medical Device De Novo Classification Process, and associated guidance document updates. The final rule,...more

Mintz - Health Care Viewpoints

Cures Act Developments: FDA Publishes CFR Amendments Exempting Class II Devices with an Interesting Addition

Since the 21st Century Cures Act became law in December 2016, we have been keeping track of the Food and Drug Administration’s actions to carry out its obligations under the relatively new law. One particular provision of the...more

Foley & Lardner LLP

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Foley & Lardner LLP on

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Beveridge & Diamond PC

FDA Requests Comments on WHO Recommendation to Classify Two Common Industrial Solvents as Psychotropic Substances

On January 27, 2015, the Food and Drug Administration (“FDA”) requested comments on a recommendation by the World Health Organization (“WHO”) to classify two common industrial solvents – gamma-butyrolactone (“GBL”) and...more

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