SUPAC-MR guidance increases allowable Level 1 content variation from 2% to 5%.
This article was originally published in The Tan Sheet
Executive Summary
FDA SUPAC-MR GUIDANCE INCREASES CONTENT VARIATION FROM 2% TO 5% for Level 1 release-controlling excipients for all extended- and delayed-release solid oral dosage forms. The Oct. 6 Scale-Up and Post-Approval Changes final guidance for Modified-Release Solid Oral Dosage Forms states that for Level 1 components and composition changes, "the total additive effect of all release-controlling excipient changes should not be more than 5% [by weight] of the total release-controlling excipients in the original approved formulation." Component and composition changes would be filed in a company annual report.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
People In Brief
Perrigo promotes in pricing, planning
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: