Inactive ingredients

13
Feb
Fingerprint

What Is It? – Identity Testing Re-visited

In earlier blogs, we have written about specific technical items related to identity testing.  However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

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06
Feb
Abstract Molecular Structure

Revisiting the “Novelty” of Novel Excipients

February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here).  In this notice, the FDA had proposed a pilot program related […]

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04
Dec
Novel Photo

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency […]

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