Law 360

MAY 17, 2023

Food and Drug Administration with questions Wednesday during oral arguments about the expedited approval the agency gave decades ago to a now widely used abortion medication, while also picking apart the arguments of anti-abortion physicians who claim they face imminent harm by the drug's approval.

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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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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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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 9, 2023

Food and Drug Administration's approval of mifepristone in 2000 slammed the agency's allegedly "decades-long pattern of delay and obfuscation" and urged the Fifth Circuit to uphold a Texas ruling that would have blocked access to the common abortifacient last month had the U.S. Anti-abortion groups challenging the U.S.

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JURIST

MAY 17, 2022

US Food and Drug Administration (FDA) Commissioner Robert Califf Monday announced the agency will investigate the delay in dispatching investigators to the Abbott Nutrition infant formula plant in Michigan. The agency subsequently filed an advisory alert to consumers in February.

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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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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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Paralegal Bootcamp

MAY 6, 2022

They can also find positions on the State level, such as the Attorney General’s Office, and finally, opportunities exist at the Federal level with various agencies such as the Department of Justice, Military, Courts, Social Security Administration, CIA, Department of Transportation, and IRS to name a few. Federal Government 5%.

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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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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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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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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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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

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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FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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FDA Law Blog

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

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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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The Crime Report

JULY 14, 2021

Deaths in 2020 jumped by 29 percent from 2019, when 72,000 people died of drug overdoses. 2020 saw the most drug overdose deaths in a year, as well as the most overdose deaths from opioids, stimulants like methamphetamine and the synthetic opioid fentanyl. The pandemic has also presented new opportunities for drug treatment.

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FDA Law Blog

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply and other food-related emergencies. The FDA Food Safety Modernization Act (FSMA) enacted in 2011, aims to ensure the U.S.

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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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FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). 156 for certain FDA-regulated products, we know what you were thinking.

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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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SCOTUSBlog

MARCH 26, 2024

The court has some of the trees right on its grounds, and they will be a backdrop to much expressive activity over today’s lone case — Food and Drug Administration v. Alliance for Hippocratic Medicine , about the agency’s 2016 and 2021 actions easing access to the abortion drug mifepristone. Unlike Dobbs v.

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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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Customs & International Trade Law

APRIL 27, 2023

The Food and Drug Administration (FDA) is now enforcing the requirement that every Food Facility Registration has a valid DUNS number. The FDA has required food facilities to register with the agency since 2002, but a DUNS number was not required up until now. What Do Food Facilities Need to Do?

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FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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FDA Law Blog

AUGUST 4, 2023

DASCA expanded the definition of “anabolic steroid” to include a drug or hormonal substance chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids and dehydroepiandrosterone) that brings to 86 substances now listed in 21 C.F.R. DASCA became law, amending the CSA, on December 18, 2014.

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Customs & International Trade Law

JULY 28, 2023

The Laurier, Washington, Port of Entry expanded operations by two hours, and the Port of Del Bonita, Montana, expanded from operating five to seven days a week. CBP has decided to maintain the expanded hours at the Sherwood, Porthill and Del Bonita ports of entry. defense industrial base.

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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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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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Customs & International Trade Law

JUNE 30, 2023

The Strategy builds upon CBP’s previous strategy to broaden the focus of integrity in the agency beyond corruption and misconduct to better reflect an enterprise-wide commitment to integrity and accountability. Announcement of approved International Trade Administration trade mission. This mission is U.S.

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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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Intelligize Blog

OCTOBER 5, 2023

Executives at pharmaceutical companies and drugstore chains likely found themselves searching for solutions to soothe their own headaches and help them sleep at night after getting news last month that the Food and Drug Administration determined a common ingredient in popular over-the-counter cold medications doesn’t work.

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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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FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA). There are obvious efficiencies with remote review of records in conserving agency resources.

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Customs & International Trade Law

DECEMBER 29, 2023

Food and Drug Administration (FDA) launched Cosmetics Direct , an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA). Along with the launch of the portal, the agency also released a portal user guide.

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