Pharma in Brief
NOVEMBER 20, 2023
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.
FDA Law Blog
AUGUST 27, 2023
Drug manufacturers have had electronic systems in place since 2017. FDA will exercise enforcement discretion concerning the implementation of the electronic interoperable exchange of information between trading partners to the package level. Guidance at 4. So what is FDA going to do? So what is FDA going to do?
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FDA Law Blog
DECEMBER 8, 2022
Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. All packaged foods served or sold on transportation carriers (e.g., By Sophia R. Gaulkin — Last week, the U.S. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,
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. By Douglas B.
Camargo
NOVEMBER 15, 2021
The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The FDA recently published the ICH’s Harmonised Guideline Q13, titled “ Continuous Manufacturing of Drug Substances and Drug Products.”
The Pharma Data
FEBRUARY 19, 2022
Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Today, the U.S. 1, 2021, through the present.
XTalks
SEPTEMBER 17, 2020
The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. an Illinois-based processor of sprouts and soy products.
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