FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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FDA Law Blog: Biosimilars

JUNE 13, 2024

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. More specifically, the Court concluded that “the Inhaler Patents do not claim the drug for which the applicant submitted the application ” (emphasis added).

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FDA Law Blog: Biosimilars

MAY 15, 2023

A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. AAFCO’s ingredient definitions are not federal regulations and do not have the force or effect of federal law. The goal is to create uniformity to facilitate interstate commerce.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. 1396r-8(k)(3). date of payment, date of shipment, date of invoice, etc.).

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Agency IQ

OCTOBER 6, 2023

If a drug was previously approved for cancer, but is now approved for a cardiology condition, it would not be considered novel. The FDA also refers to novel products as “New Molecular Entities,” or NMEs. Data on these novel approvals is published throughout the year by both CDER and CBER. of all NME approvals this year.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

The mostly redacted, then publicly available letter accompanying the basis for the recommendation stated that FDA was making a recommendation about marijuana, referring to botanical cannabis ( Cannabis sativa L.) within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. 21 U.S.C. §

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