Description
This guidance provides recommendations to pharmaceutical sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) who intend to change an analytical testing laboratory site for components, drug product containers, closures, packaging materials, inprocess materials, or drug products during the postapproval period. Analytical testing laboratories include those performing physical, chemical, biological, and microbiological testing to monitor, accept, or reject materials as well as those performing stability testing.
Scope & Applicability
Product Classes
1RTRT and CTD sections apply to drug products
Stakeholders
1Entity responsible for submitting applications under section 524B
Related CFR Sections (2)
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
See Also (8)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (Status: Final)
- Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: (Status: Final)
- New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (Status: Final)
- Submission of Quality Metrics Data Guidance for Industry (Status: Draft)
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry (Status: Final)
- Best Practices in Developing Proprietary Names for Human Prescription Drug Products; Guidance for Industry: Guidance for Industry (Status: Final)
- CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances (Status: Final)
- Potency Assurance for Cellular and Gene Therapy Products (Status: Draft)