Therapeutic equivalence

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23
Sep

Feedback from Industry on July 2022 Guidance Regarding TE Ratings for 505(b)(2) Products

By    Sep 23, 2022    505(b)(2) Applications Regulatory Affairs Therapeutic equivalence

I read a great article by Joanne S. Egolvitch in the RAPS Regulatory News this morning about elimination of Citizen Petitions for TE ratings for 505(b)(2) products (here).  The issue centers on the FDA’s (kind of wonky) requirement that 505(b)(2) applications with minor formulation changes requiring them to be submitted as an NDA also require […]

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20
Jul

Everything You May Want to Know About Therapeutic Equivalence (and More!)

By    Jul 20, 2022    ANDAs FDA NDA Regulatory Affairs Therapeutic equivalence

While most of us old timers grew up with Therapeutic Equivalence (TE) after the passage of Hatch-Waxman, the newly released draft guidance on TE (here) should be a good primer or refresher for most interested parties.  There may also be some things you did not know, like how a 505(b)(2) application can request a TE […]

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