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PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites Guidance for Industry April 1998

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to pharmaceutical sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) who intend to change an analytical testing laboratory site for components, drug product containers, closures, packaging materials, inprocess materials, or drug products during the postapproval period. Analytical testing laboratories include those performing physical, chemical, biological, and microbiological testing to monitor, accept, or reject materials as well as those performing stability testing.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1998-D-1157.

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