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Public Comment Proposed Rules Food and Drug Administration (FDA)

Quarles & Brady LLP

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

Quarles & Brady LLP on

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

Vicente LLP

Cannabis Rescheduling: The DEA's Proposed Rule and the Supporting OLC Opinion

Vicente LLP on

On May 21, 2024, the DEA finally published its proposed rule related to rescheduling marijuana and commenced a 60-day period where the public can submit comments regarding DEA's proposed move to reschedule marijuana (the...more

Bradley Arant Boult Cummings LLP

Texas Regulators to Consider Changes to Consumable Hemp Program

The Texas Health and Human Services Commission, on behalf of the Texas Department of State Health Services, recently announced that it was accepting public comments to the current rules governing consumer hemp products in the...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Troutman Pepper

FDA Proposes New Rules for Prescription Drug Labeling

Troutman Pepper on

On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more

Arnall Golden Gregory LLP

What is “Healthy Food”? FDA May Know the Answer

On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.” Since 1994, FDA has recognized that when a...more

Foster Garvey PC

Proposed Rule on “Healthy” Labeling

Foster Garvey PC on

Here is what you need to know about the FDA's recent proposed rule on "healthy" labeling. - On September 29, 2022, FDA proposed an amendment to the existing regulation (21 CFR § 101.65) on when “healthy” or similar terms...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Downey Brand LLP

FDA Announces Proposed Changes to Agricultural Water Requirements Under the Food Safety Modernization Act

Downey Brand LLP on

On December 2, 2021 the U.S. Food and Drug Administration (FDA) released a proposed rule aimed at enhancing the safety of agricultural water used on covered produce (other than sprouts). The proposed rule is the agency’s...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

Goodwin on

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

McDermott Will & Emery

EPA Approves Use of 10 Pesticide Products on Hemp

McDermott Will & Emery on

December 19th, 2019, the Environmental Protection Agency (EPA) announced its approval of 10 new pesticides for use on hemp products. EPA’s approval of nine biopesticides and one conventional pesticide provides greater...more

Bass, Berry & Sims PLC

CMS Proposal Vastly Expands Medicare Coverage for Opioid Treatment

Bass, Berry & Sims PLC on

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took the first steps toward welcoming opioid treatment programs (OTPs) into the Medicare program and expanding Medicare coverage of opioid use disorder...more

Wilson Sonsini Goodrich & Rosati

For Hemp Rule, USDA Could Go Straight to Interim Final

With the intense pressure that the U.S. Department of Agriculture (USDA) is under to draft the hemp rule in time for the 2020 planting season, it is conceivable that the department could forgo issuing a proposed rule and...more

Holland & Knight LLP

CMS Releases FY 2020 Inpatient Prospective Payment System Proposed Rule

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) on April 23, 2019, released the Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. • The proposed payment rate increase...more

Mintz - Health Care Viewpoints

FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take...more

Mintz - Health Care Viewpoints

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Holland & Knight LLP

Food and Beverage Law Update: September 2018

Holland & Knight LLP on

Labor and Employment - Jimmy John's Avoids Joint-Employer Finding in Worker Overtime Litigation - In In re: Jimmy John's Overtime Litigation, 2018 WL 3231273 (N.D. Ill. June 14, 2018), a federal district court ruled that...more

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