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USFDA Guidance: Safety Reporting for Investigational Drugs and Devices & Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Safety reporting is one of the most critical safeguards in clinical trials involving investigational drugs and medical devices. To ensure that safety information is collected, evaluated, and communicated effectively, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices (December 2025), and Sponsor Responsibilities — Safety Reporting Requirements and
Sharan Murugan
Dec 20, 20253 min read
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
Sharan Murugan
Apr 4, 20242 min read
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...
Sharan Murugan
Mar 27, 20242 min read
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...
Sharan Murugan
Feb 1, 20231 min read
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
Sharan Murugan
Dec 2, 20221 min read
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...
Sharan Murugan
Apr 24, 20221 min read
FDA's Bioavailability Guidance for NDAs or INDs- General consideration
The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...
Sharan Murugan
Apr 17, 20222 min read