BIOBATCH PACKAGING REQUIREMENTS WILL BE DOSAGE-FORM OR PRODUCT SPECIFIC

Executive Summary

BIOBATCH PACKAGING REQUIREMENTS WILL BE DOSAGE-FORM OR PRODUCT SPECIFIC in stipulating whether 100% of the bioequivalence batch for an ANDA must be packaged, FDA Office of Generic Drugs Acting Director Douglas Sporn told the National Association of Pharmaceutical Manufacturers June 15. "There will be a [policy] guide coming out that...will be dosage-form specific or product specific, and I think it should minimize the number of protocols that we should see, and it will be a lot clearer to you when 100% packaging is required and when it is not." The OGD policy and procedure guide (PPG) could be issued by the end of the summer if it clears review by division directors in the office.