FDA Law Blog

APRIL 16, 2025

is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. The panelists will also share their predictions on the increased role of state agencies and other prosecutions in the FDA space. By Andrew J. to 1:30 p.m. (ET)

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JURIST

OCTOBER 29, 2021

The US Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released ten guiding principles for the use of machine learning in medical device development. .

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Mondaq

NOVEMBER 7, 2021

Food and Drug Administration (FDA), Health Canada, and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) jointly issued a guidance document.

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Hoban Law Group

JUNE 8, 2021

Food and Drug Administration (FDA), state regulations enforced by applicable state regulatory agencies (like the Colorado Department of Public Health and Environment), organic labeling regulations enforced by the United States Department of Agriculture (USDA), and more. Supplement Facts panel); and. (5)

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Customs & International Trade Law

JULY 29, 2022

Customs and Border Protection ( CBP ) signed a Mutual Recognition Arrangement (MRA) with the customs administration of Uruguay and also signed a Joint Work Plan (JWP) with the customs administrations of Guatemala and Colombia at the Trade Facilitation and Cargo Security Summit. Food and Drug Administration.

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SCOTUSBlog

JANUARY 24, 2025

Share At oral arguments earlier this week the Supreme Court was skeptical of the Food and Drug Administrations effort to block a North Carolina-based company from challenging the denial of its application to market e-cigarettes in the conservative U.S. Court of Appeals for the 5th Circuit, based in Louisiana.

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FDA Law Blog

OCTOBER 1, 2024

Or consider Vanda’s challenge that FDA’s approval of a generic version of one of the company’s drugs violated the Appointments Clause of the Constitution (U.S. Murphy, Director of the Office of Generic Drugs’] ratification cured any Appointments Clause deficiency because it is unclear whether any statute properly authorized her appointment.

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Customs & International Trade Law

SEPTEMBER 6, 2021

Food and Drug Administration (FDA) is now auditing Foreign Supplier Verification Program (FSVP) Importers to ensure they comply with the FSVP program. If your business is importing food into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “ Importing Food in Compliance with U.S.

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FDA Law Blog

SEPTEMBER 30, 2021

See Federal Food, Drug, and Cosmetic Act (“FDCA”) Section 503A(b)(2). The matter involves a “decades old skirmish” dating back to the late 1990s, (and previously blogged about here and here ) when Congress passed the Food and Drug Administration Modernization Act (“FDAMA”), which created Section 503A.

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Customs & International Trade Law

OCTOBER 25, 2024

Here is a recap of the latest customs and international trade news: Customs and Border Protection (CBP) CBP released the September 2024 monthly update. Highlights: Identified $7.6B Bureau of Industry and Security (BIS) BIS added 26 entities to the Entity List for activities contrary to U.S. courts.

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Customs & International Trade Law

JUNE 3, 2022

On June 1, 2022, Biden’s administration has embarked on an internal debate over whether to remove some tariffs on Chinese imports, fears of rising joblessness in China and the damage done to Germany’s trade competitiveness in light of the deadline for comment from those affected by the tariffs coming up in July. On April 25, 2022, U.S.

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JURIST

JUNE 23, 2022

The US Food and Drug Administration (FDA) Thursday issued marketing denial orders (MDOs) to all JUUL Labs Inc. The agency has dedicated significant resources to review products from the companies that account for most of the U.S. products currently marketed in the US. ” FDA Commissioner Robert M. Califf, M.D.

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Law 360

JANUARY 17, 2025

Food and Drug Administration's bid to limit forum shopping by manufacturers challenging agency decisions and how much deference district courts must give to Federal Communications Commission orders.

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Customs & International Trade Law

JULY 22, 2022

Customs and Border Protection , launched their Green Trade Strategy, highlighting the agency’s efforts to combat climate change in the context of trade and provides a framework to incentivize green trade, strengthen CBP’s environmental enforcement posture, accelerate green innovation, and improve climate resilience and resource efficiency.

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FDA Law Blog

JUNE 14, 2021

Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. FDA argues that technological advances in LDTs necessitate FDA’s regulatory oversight pursuant to the Food, Drug, and Cosmetic Act (FDCA). It was all decided by administrative fiat.

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Law 360

MAY 15, 2023

Securities and Exchange Commission on Monday hit biopharmaceutical company Quanta and its CEO and executive vice president with a suit accusing the company of financial fraud over a 2021 press release the agency says misrepresented the U.S.

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LegalTalkNetwork

JUNE 27, 2024

Understanding these different roles can help you make well-informed decisions about your future, opening up new and exciting opportunities outside the traditional legal framework. Jerome Crawford, a prime example, never intended to become a cannabis attorney. She encourages others to be brave and proactive, asking, “If not you, then who?”

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FDA Law Blog

APRIL 12, 2022

This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. Food and Drug Administration , No. A key to efficient drug development is transparency. 6, 2022).

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Customs & International Trade Law

MARCH 26, 2025

Food and Drug Administration (FDA) has released summary data from mandatory registration of cosmetic product facilities and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Subsequent to the bills passage, the FDA issued regulations implementing the law.

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FDA Law Blog

OCTOBER 7, 2024

In June, the Supreme Court ruled that the SEC cannot use its administrative authority to impose civil penalties for securities fraud on the ground that these penalties violate the U.S. If FDA is prohibited from pursuing the relatively small dollar value tobacco penalty cases administratively, it could affect enforcement. 2117 (2024).

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Mondaq

NOVEMBER 8, 2021

The National Agency for Food and Drug Administration and Control (NAFDAC) regulates the importation, sale, distribution and use of food and drink products, drugs, cosmetics, devices, packaged water,

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FDA Law Blog

FEBRUARY 27, 2023

Gilbert — One misnomer that has been repeated over the years has been the reference to the “Drug Enforcement Administration” (“DEA”) as the “Drug Enforcement Agency.” This faux pas may take on new meaning given that recently the Department of Justice (“DOJ”) and DEA have argued that DEA is not an “agency” after all.

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Mondaq

DECEMBER 3, 2021

The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products.

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Mondaq

JULY 19, 2022

The National Agency for Food and Drug Administration Control which was established by Decree 15 of 1993, is the agency in charge of regulating and controlling the manufacturing,

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Law 360

MAY 5, 2021

Federal Trade Commission, limiting the agency's ability to seek equitable monetary relief under the FTC Act, will likely also restrain the U.S. Food and Drug Administration's authority under the Federal Food, Drug, and Cosmetic Act, due to similarities between the laws, say Joshua Oyster and Jenna McCarthy at Ropes & Gray.

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Law 360

NOVEMBER 17, 2023

The Federal Trade Commission's challenge to more than 100 pharmaceutical patents builds on the agency's close attention to factors impacting drug pricing, but it may not have any immediate force given the limited power of its sister agency the U.S. Food and Drug Administration, attorneys say.

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Mondaq

JULY 22, 2022

Food and Drug Administration (FDA), which could force the agency. Stacy Cline Amin spoke to Bloomberg Law about an impasse among congressional leaders on industry fees to the U.S.

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FDA Law Blog

DECEMBER 22, 2022

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. Circuit decision in Judge Rotenberg Educ.

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Mondaq

AUGUST 5, 2021

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar. biosimilar marketplace?

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Law 360

MAY 25, 2022

Food and Drug Administration inspection of a shuttered Abbott baby formula plant linked to a national shortage and bacterial contamination that sickened babies revealed "shocking" safety lapses, the head of the agency told lawmakers on Wednesday.

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FDA Law Blog

APRIL 22, 2024

Houck — Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August.

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Hoban Law Group

MARCH 26, 2021

Food and Drug Administration (“FDA”) has issued warning letters to two companies for selling cannabidiol (“CBD”) products in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). meet the monograph regulations for OTC drugs). By Garrett Graff and Ashley Simpson.

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Customs & International Trade Law

MAY 27, 2021

The Foreign Supplier Verification Programs for Food Importers (FSVP) , establishes guidelines for importers to vet their foreign manufacturers, ensuring that food products destined for the U.S. The FSVP was created under the Food Safety Modernization Act (FSMA). are safe for consumption. What Happened: FDA Opens FSVP Portal.

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Customs & International Trade Law

DECEMBER 26, 2024

Fruit juice manufacturing company and its former president plead guilty to food safety crimes. Food and Drug Administration (FDA) The FDA issued a final rule revising the requirements for when the term healthy can be used as an implied nutrient content claim in the labeling of human food products.

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The Crime Report

OCTOBER 5, 2023

In response to a spike in addiction to cocaine, meth or prescription stimulants, often in combination with opioids, the Food and Drug Administration is calling on drugmakers to develop treatments for stimulant use disorder, Jason Millman reports for Axios.

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FDA Law Blog

JULY 8, 2024

The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” Jarkesy. Here are some brief facts of the case. SEC charged George Jarkesy Jr.

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FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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