| FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Issues Draft Guidance for Industry, Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – Dose Banding Today, the U.S. Food and Drug Administration issued a draft guidance titled, Human Prescription Drug and Biological Products – Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers – Dose Banding. This draft guidance provides recommendations to assist applicants in incorporating information into human prescription drug labeling on how to dose patients with drugs that have weight- or body surface area-based doses when using ready-to-use containers offering a range of strengths (for example, as provided in pre-mixed infusion bags).
The recommendations outlined in the draft guidance are intended for applicants seeking to include information in labeling under a supplement to an existing new drug application (NDA) or 351(a) biologics license application (BLA) or for an original NDA or 351(a) BLA.
For information on the draft guidance and how to comment, please see the Federal Register Notice.
| | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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