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Recordkeeping Requirements Food and Drug Administration (FDA)

Wiley Rein LLP

CISA’s Proposed Cyber Incident Reporting Requirements Would Hit a Range of Industries and Sectors

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The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more

Davis Wright Tremaine LLP

Where Does Your Food Come From? The FDA Really Wants to Know

In November 2022, the U.S. Food and Drug Administration ("FDA") finalized a rule imposing additional recordkeeping requirements for certain foods to "help the Agency rapidly and effectively identify recipients of foods to...more

Greenberg Glusker LLP

Modernization of Cosmetics Regulation Act - What Companies Need to Know

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Beginning on December 29, 2023, the Modernization of Cosmetics Regulation Act (MOCRA) became effective. Signed into law on December 29, 2022, MoCRA significantly expands the U.S. Food and Drug Administration’s (FDA) authority...more

Husch Blackwell LLP

MoCRA: What’s on the horizon for PFAS?

Husch Blackwell LLP on

This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s...more

Holland & Knight LLP

A Look Into the FDA and USDA Regulatory Regimes

Holland & Knight LLP on

In the next episode of the "Legal Bites Podcast" series, Food and Beverage Litigation Team leader Nathan Adams and Practice Development Manager Kristina Merritt speak with Public Policy & Regulation attorney Sara Klock, who...more

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Regulators Must Write Cloud-Specific Guidance

Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Stocking Naloxone in the Workplace: What Employers Need to Consider

It is well known that opioid overdoses have occurred at epidemic levels in the United States for years. According to the U.S. Centers for Disease Control and Prevention (CDC), opioid overdose deaths have increased from 21,089...more

Venable LLP

Prepare Now for the New FDA Requirements for Cosmetics Companies

Venable LLP on

Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

Epstein Becker & Green

FDA Significantly Reforms Cosmetics Regulations for First Time in Over 80 Years

In the first major reform of cosmetics regulations since the Federal Food, Drug & Cosmetics Act (FDCA) became law in 1938, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expands the authority of...more

Foley & Lardner LLP

Modernization of Cosmetics Regulation Act of 2022: What You Need to Know

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On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more

ArentFox Schiff

Where In the World Did My Food Come From: FDA’s Food Traceability Rule Takes Effect

ArentFox Schiff on

On January 20, 2023, the US Food and Drug Administration’s (FDA) final rule on food traceability will take effect. Regulated entities will have a three-year compliance period, with a current compliance date of January 20,...more

MoFo Life Sciences

Congress Expands FDA Authority Over Cosmetics Regulation

MoFo Life Sciences on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more

Perkins Coie

FDA Publishes Final Rule Requiring Additional Traceability Records for Certain Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) published a final rule creating additional recordkeeping requirements for foods listed on the Food Traceability List. The final rule was published in the Federal Register on...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

Morrison & Foerster LLP - Class Dismissed

Water Is In, White Bread Is Out: “Healthy” Gets A New Look In 2023

For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies?...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

Husch Blackwell LLP

FDA Issues Final Guidance for Voluntary Recalls

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Earlier this month, the U.S. Food and Drug Administration (“FDA”) completed guidance to help companies remove violative products from the market in a swift and effective manner. The guidance describes the precautionary steps...more

McDermott Will & Emery

FDA Issues Final Guidance for Initiation of Voluntary Recalls

The US Food and Drug Administration (FDA) published its Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (final guidance) on March 4, 2022. The final guidance describes how...more

McDermott Will & Emery

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

MoFo Employment Law Commentary (ELC)

UNPACKING THE NEW OSHA ETS FOR COVID-19 VACCINES AND TESTING

On November 4, 2021, the Occupational Safety and Health Administration (OSHA) released its highly anticipated emergency temporary standards for COVID-19 (the “ETS”) along with a landing page on its website with various...more

Fox Rothschild LLP

An Overview of the Key to NYC Vaccine Mandate Program

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New York City’s Key to NYC mandate for indoor dining, gyms and entertainment venues is now in effect. Below are the requirements of the mandate as set forth in the various Executive Orders that have been issued, as well as in...more

Fox Rothschild LLP

NYC Issues Details Of Vaccine Mandate For Indoor Dining, Gyms And Entertainment Venues

Fox Rothschild LLP on

New York City Mayor Bill de Blasio issued an Executive Order on August 16, 2021 setting forth the requirements of the “Key to NYC” vaccine mandate that was announced earlier this month for indoor dining, gyms and...more

Goodwin

Common GCP Bioresearch Monitoring Violations

Goodwin on

The U.S. Food and Drug Administration’s (FDA’s) Office of Bioresearch Monitoring Operations (OBIMO) oversees domestic and foreign agency field inspections for clinical and non-clinical research. In particular, OBIMO manages...more

Morgan Lewis - Well Done

FDA’s Latest Initiatives Seek Input from Industry to Develop Food Traceability Tools

To enhance its food traceability objective through the use of technology that strengthens the food safety system, the US Food and Drug Administration (FDA) unveiled, on May 19, its latest initiative through which it hopes to...more

Vicente LLP

Massachusetts Cannabis Retailers Can Now Sell Hemp Products: What Retailers Need To Know

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The Massachusetts Cannabis Control Commission recently voted to issue Guidance for the Retail Sale of Hemp to clarify requirements and restrictions on the retail sale of certain types of hemp products by licensed adult-use...more

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