Cosmetics Drugs Generic Drugs Regulation 
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.
FDA Law Blog
MARCH 6, 2024
The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.
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Camargo
SEPTEMBER 8, 2021
Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. Final Regulation Issued for “Intended Use”.
The Pharma Data
MARCH 15, 2022
Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.
FDA Law Blog
JUNE 2, 2022
Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.
FDA Law Blog
JUNE 28, 2023
This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act) , is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs. 1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023.
FDA Law Blog
AUGUST 21, 2023
FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.
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