Zdrowie i gospodarka · 28/04/1998

Draft Guidance for Industry on SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum.'' This draft guidance is intended to provide insight and recommendations to pharmaceutical sponsors of new drug applications (NDA's) and abbreviated new drug applications (ANDA's) who wish to change equipment during the postapproval period.