Regulatory Blog

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...

Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...

Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...

Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...

The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...