Category: Regulatory affairs

Black box warnings: What to know Understanding Black Box Warnings: A Crucial Guide Black box warnings, also known as boxed warnings, represent the most serious level of caution that the U.S. Food and Drug...

Information about Nitrosamine Impurities 2024 in API and finished pharmaceutical products Nitrosamine Impurities: The FDA has released a revised guidance titled  “Control of Nitrosamine Impurities in Human Drugs,” which outlines the agency’s updated approach...

Analysis of Particle Size Distribution D10​/D50/D90 Analysis particle size distribution is crucial for quality control and research, as it directly impacts various material properties. These properties include flow characteristics, reactivity, abrasiveness, solubility, extraction efficiency,...

Biologics Similar: Principles for Development of Biologics Similar Biologics Similar biologics are created through a systematic process aimed at demonstrating their similarity to a reference biologic by conducting thorough characterization studies of molecular and...

Nitrosamine USFDA Guidelines: Managing Nitrosamine Contaminants in Human Medications Nitrosamine Earlier today (September 4, 2024), the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration issued an updated version of...

SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template SAHPRA South Africa The South African Health Products Regulatory Authority (SAHPRA) has issued new instructions for \”eCTD Validation and Technical Screening...