Regulatory Blog

Last week, two pivotal updates were introduced: the Union Health Ministry proposed major amendments to the New Drugs and Clinical Trials...

Developing drug products across multiple strengths is a common strategy in pharmaceutical formulation, allowing dose flexibility and...

Recently 30th October, 2025 the U.S. Food and Drug Administration (FDA) issued guidance titled " M13A: Bioequivalence for...

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated regulatory guidance on the conduct of bioequivalence...

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...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 (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...

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

The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...

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(o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...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

On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...