News & Analysis as of

Notice of Proposed Rulemaking (NOPR) Food and Drug Administration (FDA)

Foley & Lardner LLP

USPTO Publishes Drug Patent and Exclusivity Study Report

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The U.S. Patent and Trademark Office (USPTO), in conjunction with the Food and Drug Administration (FDA) and in response to January 2022 and April 2022 letters from Senator Thom Tillis (R-NC), has published a report examining...more

King & Spalding

DEA's Proposed Rule to Reschedule Marijuana Could Reduce Obstacles to Medical Research but Public Input Is Needed to Fill in...

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On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more

Foley & Lardner LLP

The FDA Wants To Reschedule Cannabis. Does That Mean All Employees Can Soon Legally Use It?

Foley & Lardner LLP on

On May 21, 2024, the Drug Enforcement Agency (DEA) issued a notice of proposed rulemaking indicating that the U.S Food and Drug Administration (FDA) intends to transfer marijuana from Schedule I to Schedule III of the...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

Mintz

Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA

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Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...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

Mintz - Health Care Viewpoints

FDA Faces Critical Deadlines in 2024, Even Without an Election Looming

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more

Mintz - Health Care Viewpoints

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

Mintz - ML Strategies on

Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

ArentFox Schiff

Prop 65 Roundup - November 2023

ArentFox Schiff on

California Bans Several FDA-Authorized Food Additives; New York May Soon Follow - On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety...more

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

Quarles & Brady LLP on

On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Epstein Becker & Green

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

Epstein Becker & Green on

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2023

In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more

Jenner & Block

New OEHHA Proposition 65 Acrylamide Warning Label Does Little to Resolve Pending First Amendment Challenges - Update

Jenner & Block on

The California Office of Administrative Law (OAL) recently approved a revised Proposition 65 warning label requirement for the use of acrylamide in food and beverages. California’s Office of Environmental Health Hazard...more

Bass, Berry & Sims PLC

Harmonization is Here: What FDA’s Proposed Human Subject Protection Rules Mean for You

Bass, Berry & Sims PLC on

On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more

Wiley Rein LLP

FCC Proposes Broadband “Nutrition” Label Requirement - UPDATED February 2022

Wiley Rein LLP on

*This alert was originally published on January 28, 2022 and updated on February 4, 2022. On January 27, 2022, the Federal Communication Commission (FCC or Commission) moved to implement a provision of the bipartisan...more

Wiley Rein LLP

FCC Proposes Broadband “Nutrition” Label Requirement

Wiley Rein LLP on

On January 27, 2022, the Federal Communication Commission (FCC or Commission) moved to implement a provision of the bipartisan Infrastructure Investment and Jobs Act by adopting a Notice of Proposed Rulemaking (NPRM) that...more

King & Spalding

Trump Administration Continues to Promote Drug Importation as a Way to Lower the Cost of Prescription Drugs

King & Spalding on

On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more

Wilson Sonsini Goodrich & Rosati

Administration Again Attempts to Lower Drug Prices

In 2018, the administration published its Blueprint to Lower Drug Prices for U.S. citizens. The Blueprint included 12 proposed actions by the Department of Health and Human Services (HHS)....more

Holland & Knight LLP

Healthcare Law Update: December 2018

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Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more

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