U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry
  1. Regulatory Information

GUIDANCE DOCUMENT

Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry September 2017

Final

Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry

Docket Number:
FDA-2015-D-4644
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to FDA. The program is open to companies that intend to include the technology as part of a regulatory submission including investigational new drug applications (IND), original or supplemental new drug applications (NDA), abbreviated new drug applications (ANDA) or biologic license applications (BLA), or application-associated Drug Master Files (DMF) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance. This program does not cover products reviewed by the Center for Biologics Evaluation and Research.


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:

Division of Dockets Management (HFA- 305)
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-2015-D-4644.