USA – FDA drafts guidance, orders on minor changes to OTC drugs and packaging
The Food and Drug Administration (FDA) has released draft guidance and a proposed administrative order regarding the documentation required for minor dosage form changes...
USA – FDA approves darolutamide for metastatic castration-sensitive prostate cancer
On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The...
USA – FDA proposes downgrading drug color additive changes to CBE-30
The US Food and Drug Administration (FDA) has released draft guidance for pharmaceutical manufacturers wishing to replace a color in a drug product. These...
USA – FDA sets stricter approval standards for COVID vaccines
Over the past 5 years, the United States has moved toward an annual Covid-19 booster program. Each fall, Covid-19 booster shots are developed, alongside...
USA – FDA to expand unannounced foreign inspections after Trump executive order
The US Food and Drug Administration (FDA) on Tuesday announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that...
USA – FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies...
Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of...
USA – FDA approves first treatment for adults with complement 3 glomerulopathy, a rare...
The U.S. Food and Drug Administration has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria.
Fabhalta is...
USA – FDA makes flu vaccine recommendations after canceled VRBPAC, closed-door meeting
After canceling a routine meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review the composition of the 2025-2026 influenza vaccine,...
USA – Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials
Manufacturers might be incentivized to speed up completion of confirmatory trials for their accelerated approval drugs if they are restricted from using a brand...
Canada – Submitting risk management plans guidance document: Overview
This guidance document on submitting risk management plans, published on February 24, 2025, will come into effect on July 1, 2025.
In the meantime the Guidance...
