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What is a natural health product? Health Canada’s findings upheld by Federal Courts

Pharma in Brief

The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. Natural health product vs. regulated drug In Winning Combination Inc. In its August 16, 2023 decision in Le-Vel Brands, LLC v.

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It’s Groundhog Day for Food Labeling, Again: The Food Labeling Modernization Act is Back

FDA Law Blog

The latest version of the bill again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. Regulation to establish levels of allulose, polydextrose, sugar alcohols or isolated fibers above which require a warning that the food contains levels that cause “deleterious health effects.”.

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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law Blog

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. billion in pharmaceutical sales from 2021. 2022 Revenue: Pfizer reported an annual revenue of $100.33 billion, a 42.74

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‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules

FDA Law Blog

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider. Nor is it unusual for FDA to give FDA a deadline (which is often missed).

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The Drug Reimportation Law Curtails Wholesale Not Personal Importation: Who Knew?

Pharmacy Checkers

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. J)(2) Waiver authority. for drug safety.