As discussed in a recent Lachman blog Revised Q1 Draft Stability Document Issued by FDA, the draft guidance titled Q1 Stability Testing of Drug Substances is a consolidated revision of ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C. This draft guidance provides guidance on product categories, such as advanced therapy medicinal products, vaccines, and other […]
In combing through regulations.gov this morning, I found a July 7, 2025 petition (here) submitted by a physician citing concerns about “prematurely expiring drugs.” His point is that many drugs likely would still meet all of the required specifications outlined in an application well past their labeled expiration dates, which could positively impact drug shortages and […]
The newly revised and expanded draft guidance titled Q1 Stability Testing of Drug Substances and Drug Products (here) was published today. This draft guidance represents “a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July […]
On April 11, 2025, the ICH endorsed a draft guidance titled “Stability Testing of Drug Substances and Drug Products Q1” (here). This is a large, comprehensive guidance that applies to stability testing of chemically synthesized drug substances, biologics, vaccines, gene therapies, and combination products. The guidance addresses primary stability studies, commitment, ongoing and stability studies […]
Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so without (in most cases) performing additional stability studies. The Agency notes that it “received a few comments on the revised draft […]
