Description
On November 30, 1995, the Scale-up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR) was published. Since then a number of questions have arisen in interpreting the Guidance as it applies to specific situations encountered or that could be encountered in the pharmaceutical industry. The purpose of this letter is primarily to share with you the questions that have been asked most frequently or that we consider the most significant. Also included are the Center's responses to these questions. The responses were developed and concurred with by the Office of New Drug Chemistry and Office of Generic Drugs, Center for Drug Evaluation and Research (CDER). We believe the sharing of the information will result in furthering the use of the Guidance to increase regulatory flexibility for industry.
Scope & Applicability
Product Classes
1Applicable to tablets, capsules, and granules/powders for oral suspension.
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1Specifications and intended use of an excipient
Related CFR Sections (1)
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
See Also (8)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
- Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)