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Friday, June 21, 2024 3:42:05 PM
Quote:
Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.
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