Approvable letter

Approvable letters, and the related non-approvable letters (alternately not-approvable letters), were 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 were intended to let manufacturers know how much work is needed on their applications.[1] Non-approval letters were rejections of a drug's application.[2] Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110.[3]

In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval.[4][5]

  1. ^ a b "F.D.A. Revises Its Letter for Nonapproval of Drugs". The New York Times. 2008-07-10. Retrieved 2018-09-28.
  2. ^ "FDA issues non-approvable letter for ISTA's T-Pred". ophthalmologytimes.com. 2007-05-05. Archived from the original on September 29, 2018. Retrieved 2018-09-28.
  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.
  4. ^ "CFR - Code of Federal Regulations Title 21". fda.gov. 2018-04-01. Archived from the original on November 28, 2002. Retrieved 2019-07-03.
  5. ^ "Complete Response Letter Final Rule". FDA. 9 February 2018. Archived from the original on September 27, 2019. Retrieved 23 July 2019.
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