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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2014]
[CITE: 21CFR314.100]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Subpart D--FDA Action on Applications and Abbreviated Applications

Sec. 314.100 Timeframes for reviewing applications and abbreviated applications.

(a) Except as provided in paragraph (c) of this section, within 180 days of receipt of an application for a new drug under section 505(b) of the act or an abbreviated application for a new drug under section 505(j) of the act, FDA will review it and send the applicant either an approval letter under 314.105 or a complete response letter under 314.110. This 180-day period is called the "initial review cycle."

(b) At any time before approval, an applicant may withdraw an application under 314.65 or an abbreviated application under 314.99 and later submit it again for consideration.

(c) The initial review cycle may be adjusted by mutual agreement between FDA and an applicant or as provided in 314.60 and 314.96, as the result of a major amendment.

[73 FR 39609, July 10, 2008]

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