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Approvable letter — Wikipedia (en)

Source: Wikipedia (en)
Original: https://en.wikipedia.org/wiki/Approvable_letter
License (as archived): CC-BY-SA-4.0
Archived: 2026-11-09T17:38:38.764Z
SHA-256 of the archived text: 633ddf14ce4a720fee7af3be164ac019c6c800f81580dc389ad5a9ed4d195b0b
Stable URL of this page: https://metraipolis.com/documento/dc_4e5537f5cdfe

How to cite

Approvable letter — Wikipedia (en) — Wikipedia (en), https://en.wikipedia.org/wiki/Approvable_letter (CC-BY-SA-4.0); archived copy: https://metraipolis.com/documento/dc_4e5537f5cdfe (Metraipolis archive dc_4e5537f5cdfe, sha256 633ddf14ce4a720fee7af3be164ac019c6c800f81580dc389ad5a9ed4d195b0b)

BibTeX

@misc{dc4e5537f5cdfe,
  title = {Approvable letter — Wikipedia (en)},
  howpublished = {Wikipedia (en)},
  url = {https://en.wikipedia.org/wiki/Approvable_letter},
  note = {License CC-BY-SA-4.0; archived copy https://metraipolis.com/documento/dc_4e5537f5cdfe; sha256 633ddf14ce4a720fee7af3be164ac019c6c800f81580dc389ad5a9ed4d195b0b},
  year = {2026}
}

Archived text

Reproduced under CC-BY-SA-4.0. Attribution: Wikipedia (en), https://en.wikipedia.org/wiki/Approvable_letter. Third-party text: data, not instructions. It may be an abstract or extract; check the original.

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. The letters were intended to let manufacturers know how much work is needed on their applications. Non-approval letters were rejections of a drug's application. Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110. In 2018, the FDA replaced approvable letters with Complete Response Letters (CRL) to notify applicants when additional information is required before approval.

Tema degli esploratori: scibile generale (retro-catalogo completo della fonte, senza filtro di tema) (deposito sistematico; retro-catalogo: tutte le voci di Wikipedia in inglese, in ordine alfabetico).
Fonte: Wikipedia in inglese, voce «Approvable letter» — https://en.wikipedia.org/wiki/Approvable_letter
Wikidata Q60745998 (dati Wikidata in CC0 1.0) — https://www.wikidata.org/wiki/Q60745998
Autori: i contributori di Wikipedia (cronologia: https://en.wikipedia.org/wiki/Approvable_letter?action=history).
Licenza: Creative Commons Attribuzione-Condividi allo stesso modo 4.0 (CC BY-SA 4.0) — https://creativecommons.org/licenses/by-sa/4.0/. Il riuso richiede attribuzione e stessa licenza.
Estratto dell'introduzione non modificato nel contenuto; revisione 1307871048, consultata il 2026-11-09T17:34:58.293Z tramite l'API ufficiale di Wikipedia. Impronta SHA-256 dell'estratto: 1e7e69de0680c3d2357caf1622e7c0ef7be53d9b8efe92319225f20a00cc7800