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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Cosmetics Compliance Generic Drugs Regulation 59

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.

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FDA Approval Generic Drugs Production Drugs 52

FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Food and Drug Administration (FDA) to first grant a suitability petition. Both bills – S.

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Generic Drugs Drugs Branding Production 40

FDA Law Blog

APRIL 30, 2021

1462 , the “ Simplifying the Generic Drug Application Process Act ,” and S.1463 1462, the “Simplifying the Generic Drug Application Process Act.”. Simplifying the Generic Drug Application Process Act (S. Food and Drug Administration (FDA) to first grant a suitability petition. Both bills – S.

Generic Drugs 40

Generic Drugs Drugs Branding Production 40

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Production Insulin Branding Generic Drugs 78

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Just like it was over a decade ago in Pliva v. billion in damages were brought between 1980 and 1986.

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FDA Approval Production Drugs Generic Drugs 40

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . The medications that we obtain in the U.S., and other high-income countries.

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Generic Drugs Manufacturing Regulation Drugs 68