Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
The U.S. Food and Drug Administration (FDA) has issued a guidance document titled “Computer Software Assurance for Production and Quality System Software,” aimed at…
Read more →Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (FDA) has released an essential guidance document titled “Postmarketing Safety Reporting for Combination Products.” This guidance provides clarity…
Read more →Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
The U.S. Food and Drug Administration (FDA) has issued detailed guidance on the nonproprietary naming of biological products to enhance pharmacovigilance and ensure patient…
Read more →Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
The U.S. Food and Drug Administration (FDA) has issued a comprehensive guidance document titled Adaptive Designs for Clinical Trials of Drugs and Biologics. This…
Read more →Drug Product Tracing: The Effect of Section 585 of the FD&C Act
The U.S. Food and Drug Administration (FDA) has issued comprehensive guidelines on the mandatory reporting of serious adverse events associated with dietary supplements. This…
Read more →FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act
The U.S. Food and Drug Administration (FDA) has provided comprehensive guidance on postmarketing safety reporting (PMSR) requirements for combination products. This document, titled Postmarketing…
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