Approvable letter

Approvable letters, and the related non-approvable letters (alternately not-approvable letters), are notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development.[1] The letters are intended to let manufacturers know how much work is needed on their applications.[1] Non-approval letters are rejections of a drug's application.[2]

Approvable and non-approvable letters are covered under Title 21 of the Code of Federal Regulations, section 314.110.[3]

Guidelines

Approvable letters are issued to applicants at the end of the FDA's review period to indicate that the application or abbreviated application is basically approvable providing certain issues are resolved. It's an indication that the application substantially meets FDA requirements if specific conditions, such as labeling changes, are agreed to. The letter describes what is required by the FDA.[3]

Applicants have 10 days after the date of the approvable letter to amend the application, notify of intent to file for an extension, withdraw the application, request a hearing or notify that they agree to an extension.[3]

References

  1. 1 2 "F.D.A. Revises Its Letter for Nonapproval of Drugs". nytimes.com. 2008-07-10. Retrieved 2018-09-28.
  2. ↑ "FDA issues non-approvable letter for ISTA's T-Pred". ophthalmologytimes.com. 2007-05-05. Retrieved 2018-09-28.
  3. 1 2 3 "Title 21 - Food and Drugs. CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED). 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". gpo.gov. 2006-04-01. Retrieved 2018-09-28.


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