Regulatory Blog

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...

As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...

According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...

The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...

European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...