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url: https://www.federalregister.gov/documents/2026/07/29/2026-15285/product-specific-guidances-revised-draft-guidances-for-industry-availability
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published_at: '2026-07-29T00:00:00Z'
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updated_at: '2026-07-29T09:13:04Z'
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attribution: 'Source: Office of the Federal Register, National Archives and Records
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summary: The Food and Drug Administration (FDA or Agency) is announcing the availability
  of additional revised draft product-specific guidances. The draft guidances provide
  product-specific recommendations on, among other things, the design of bioequivalence
  (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal
  Register of June 11, 2010, FDA announced the availability of a guidance for industry
  entitled "Bioequivalence Recommendations for Specific Products" that explained the
  process that would be used to make product-specific guidances available to the public
  on FDA's website. The draft guidances identified in this notice were developed using
  the process described in that guidance.
summary_source: official
summary_en: The Food and Drug Administration (FDA or Agency) is announcing the availability
  of additional revised draft product-specific guidances. The draft guidances provide
  product-specific recommendations on, among other things, the design of bioequivalence
  (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal
  Register of June 11, 2010, FDA announced the availability of a guidance for industry
  entitled "Bioequivalence Recommendations for Specific Products" that explained the
  process that would be used to make product-specific guidances available to the public
  on FDA's website. The draft guidances identified in this notice were developed using
  the process described in that guidance.
provenance:
  doc_id: 2026-15285
  doc_id_scheme: fr_docnum
  issuer:
  - Health and Human Services Department
  - Food and Drug Administration
  doc_type: Notice
  subtype: null
  action: Notice of availability.
  significant: null
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  type: organization
- name: biz_industry
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title: Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
---

# Product-Specific Guidances; Revised Draft Guidances for Industry; Availability

## TL;DR
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.

## Key Points
- (なし)

## Details
(本文なし。リンク先参照)

## Source
元記事: [Product-Specific Guidances; Revised Draft Guidances for Industry; Availability](https://www.federalregister.gov/documents/2026/07/29/2026-15285/product-specific-guidances-revised-draft-guidances-for-industry-availability) — published 2026-07-29T00:00:00Z