Regulatory Blog

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Jun 26, 20221 min

USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format

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

Jun 16, 20221 min

USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication

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

Jun 3, 20221 min

TGA guidance on Testimonials & Endorsements in Advertising

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

May 26, 20221 min

Free eBook- CAPA in the Pharmaceutical and Biotech Industries

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

May 26, 20221 min

SAPHRA - Guideline on Availability of Medicines for Use in a Public Health Emergency (PHE)

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

May 26, 20221 min

EMA - Guideline on Treatment of Bacterial Infections

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

May 22, 20221 min

USFDA's Guidance on Safety Considerations for Container Labels and Carton Labeling

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