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Cancer Regulatory Requirements Food and Drug Administration (FDA)

Goodwin

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

Goodwin on

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

Mayer Brown

Regulatory and Legal Implications of the Surgeon General’s Call For Cancer Warning On Alcohol Labels

Mayer Brown on

On January 3, 2025, outgoing US Surgeon General Dr. Vivek Murthy released a new advisory outlining the alleged causal link between alcohol consumption and cancer, claiming “numerous high-quality observational studies and...more

K&L Gates LLP

FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs

K&L Gates LLP on

On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

ArentFox Schiff

US Surgeon General Advises on Link Between Alcohol and Cancer, Recommends Cancer Warnings on Alcohol Labels; Alcohol Beverage...

ArentFox Schiff on

On January 3, the US Surgeon General issued an advisory on the association between alcohol and the risk of cancer. The alcohol beverage industry has swiftly responded highlighting conflicting studies and federal guidelines....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | May 2018 #4

Advocacy Groups Urge Senate to Support NOSB - A group of advocacy organizations has sent a letter asking the leaders of the Senate Committee on Agriculture, Nutrition & Forestry to “fully support organic agriculture in the...more

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