Unlocking the Future of Drug Development: How the FDA’s New Radiolabeled Mass-Balance Study Guidance Is Changing the Game
🧠 Article: The U.S. Food & Drug Administration (FDA) has released a pivotal guidance document — “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies” — which outlines its current thinking on when and how to conduct human radiolabeled mass-balance studies of investigational drugs. U.S. Food and Drug Administration Here’s a breakdown of what this […]
E20 Adaptive Designs for Clinical Trials
Introduction & Context In June 2025, the International Council for Harmonisation (ICH) released a draft guideline titled “Adaptive Designs for Clinical Trials (E20)”, currently under public consultation. U.S. Food and Drug Administration This draft, intended to harmonize global regulatory and scientific expectations, addresses the use of adaptive designs in confirmatory clinical trials (i.e., trials intended […]
Data and information required for grant of permission to conduct bio availability and bioequivalence study of a new drug or investigational new drug
Data elements for reporting serious adverse events occurring in a clinical trial or bio availability or bioequivalence study
Data required to be submitted by an applicant for conduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength
Data to be submitted along with application to conduct clinical trial or import or manufacture of a Phytopharmaceutical drug in the country (India)
Data generated by Applicant:
Data required to be submitted by an applicant forconduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength
Data to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs for sale in the country
Requirements for drug approval with new claims
In case a drug already approved by the Central Licencing Authority for certain claims, which is now proposed to be clinically tried or marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration or novel drug delivery system (NDDS), the requirements of data and information […]