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FDA's CDER Handbook - Undergoing Revision

By James M. Beck and Mark Herrmann

One of us (Bexis) was updating a book chapter on "What Litigators Need to Know About the FDA," and wanted to cite to the CDER (Center for Drug Evaluation and Research) Handbook concerning its definition of "untitled letter." But the link to the CDER Handbook wasn't active on the FDA's website. Well, that prompted an email to CDER's Ombudsman. The response was that the CDER handbook is under revision and the link would be down until that revision was finished. The Ombudsman was helpful, however, and provided a copy of the old - under revision - version of the CDER Handbook.

We thought (since we couldn't easily find it elsewhere online) that there may be others who would want access to the CDER Handbook pending revision so here's a link to the copy we received. Again -- we caution (for the fourth time) that this copy does not completely reflect current FDA policy, since it's under revision.

Full post as published by Drug and Device Law on August 14, 2009 (boomark / email).