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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog

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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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The Pharma Data

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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The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

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The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

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. More than a few have taken far longer—literally decades.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

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 “genericdrugs of the biopharma world.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

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. . There are 19,000 approved prescription drugs for marketing in the U.S. Far from it.