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United States
Exponent
The 2022 Modernization of Cosmetics Regulation Act requires cosmetics manufacturers update facility registrations and product listings by July...
Exponent
The agency has published new draft guidance to support manufacturer compliance with special controls...
Axinn Veltrop & Harkrider
Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with "a reasonable expectation of success."
Diaz Trade Law
Last week, FDA's Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database.
Goodwin Procter LLP
On April 4, 2024, Bristol Myers Squibb ("BMS") and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed ...
Dickinson Wright PLLC
The Food and Drug Administration regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics.
Arnold & Porter
On Feb. 6, 2024, the U.S. FDA issued a final guidance, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.
Goodwin Procter LLP
On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo's ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
Shearman & Sterling LLP
On March 30, 2024, Judge Araceli Martínez-Olguín of the Northern District of California granted a motion to dismiss a putative class action against a biotechnology company that develops and sells skin treatment drugs and certain of its officers.
Jones Day
The Situation: The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral...
Perkins Coie LLP
On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance).
Foley Hoag LLP
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate.
Arnold & Porter
11. COVID-19 and Life Sciences, the US government has used a wide variety of
public procurement and funding strategies for needed medical
countermeasures during the pandemic.
Stites & Harbison PLLC
In December 2023, the U.S. Supreme Court heard oral arguments in the case of Harrington v. Purdue Pharma, L.P., Case No. 23-124. Purdue Pharma is the drug manufacturer of the prescription opioid...
Fenwick
The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).
Foley & Lardner
Antibody Drug Conjugates (ADCs) represent an innovative class of potent anti-cancer compounds. ADCs are widely used in the treatment of hematologic malignancies and solid tumors.
Greenberg Traurig, LLP
On April 1, 2024, the U.S. Food and Drug Administration (FDA) issued a statement reminding stakeholders, especially animal drug manufacturers and veterinarians...
Sheppard Mullin Richter & Hampton
The Federal Trade Commission ("FTC") has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency's...
Braumiller Law Group, PLLC
The intricate interplay between trade and food security has emerged as a vital global issue, one that is closely interwoven with the tapestry of international conflicts and political instability.
Greenberg Traurig, LLP
A new law regulating third-party food delivery went into effect in Florida on April 2, 2024. In an effort to help restaurants curb unauthorized third-party delivery business practices...
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