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e-CFR data is current as of August 7, 2020

Title 21Chapter ISubchapter DPart 314Subpart C → §314.98


Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart C—Abbreviated Applications


§314.98   Postmarketing reports.

(a) Each applicant having an approved abbreviated new drug application under §314.94 that is effective must comply with the requirements of §314.80 regarding the reporting and recordkeeping of adverse drug experiences.

(b) Each applicant must make the reports required under §314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.

[79 FR 33089, June 10, 2014]

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