Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application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...
Clinical Research Solutions
FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments
Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments.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...
Clinical Research Solutions
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...