thought leadership

FDA BLA

January 26, 2024

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the...

FDA North America

July 27, 2022

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...

FDA North America

July 21, 2022

Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”

Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the...

FDA North America

May 9, 2022

FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments

Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This guidance describes the benefit-risk principles applied by FDA...

ANDA FDA

April 27, 2022

Providing Submissions in Electronic Format — Postmarketing Safety Reports

GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...