CENTER FOR DRUG EVALUATION AND RESEARCH

DIVISION of
DRUG INFORMATION

Your source for the latest drug information. Know the moment it happens.

​

FDA Reopens Comment Period on Notice of Possible Revisions to Guidances for Industry Scale-Up and Postapproval Changes

Today, FDA reopened the comment period for an additional 30 days for the docket to solicit public comment on the following guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms:

• SUPAC-IR: Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
• SUPAC-IR Questions and Answers about SUPAC-IR Guidance
• SUPAC-SS: Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
• SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
• SUPAC: Manufacturing Equipment Addendum

FDA uses a risk-based approach for recommending the reporting of chemistry, manufacturing, and controls (CMC) changes that could affect the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. Using a risk-based approach reduces regulatory burden by clarifying what reporting is necessary based on the likelihood that changes will affect the safety or effectiveness of a drug product. The SUPAC guidances describe the recommended testing and documentation that should be submitted for component and composition changes, manufacturing process and equipment changes, manufacturing scale changes, and manufacturing site changes.

The core principle of a risk-based approach for recommending the reporting of CMC changes as described in the SUPAC guidances remains relevant, but the guidances may benefit from updates to ensure they reflect current expectations, risk assessment strategies, and contemporary scientific and technical considerations. Therefore, FDA is seeking feedback and suggestions about possible revisions to the guidances.

This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov.