In the rapidly evolving landscape of regulated industries, 21 CFR Part 11 compliance remains a cornerstone of digital transformation and regulatory adherence. This USFDA regulation establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and…
A USFDA Warning Letter (WL) is more than a mere correspondence; it is a public declaration of significant non-compliance with the Federal Food, Drug, and Cosmetic Act, posing an immediate, existential threat to a pharmaceutical, medical device, or biologics operation.…
For global pharmaceutical and medical device manufacturers, particularly those operating in high-volume markets like the US and India, the receipt of an FDA Form 483, Inspectional Observations, is not merely a documentation step—it is a critical inflection point. In the…
For pharmaceutical manufacturers, especially those eyeing the lucrative United States market, USFDA pharma compliance and Inspection readiness is not merely a regulatory hurdle; it is the cornerstone of commercial viability and corporate reputation. The U.S. Food and Drug Administration (FDA)…
The U.S. Food and Drug Administration (FDA) granted Accelerated Approval to FORZINITY (elamipretide) on September 19, 2025, marking a pivotal moment as the first approved treatment for Barth Syndrome (BTHS) in eligible patients. This rare, X-linked, infantile-onset disease previously relied…
In a significant development for oncology practice, the U.S. Food and Drug Administration (FDA) on September 19, 2025, granted approval for Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a new subcutaneous formulation of the widely used PD-1 inhibitor, pembrolizumab. This approval…
On August 12, 2025, the U.S. Food and Drug Administration (FDA) approved Brinsupri (brensocatib), a novel, first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older. This approval marks a…
The recent FDA approval of WAYRILZ (rilzabrutinib) marks a significant advancement for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments. Developed by Genzyme, a Sanofi company, this novel Bruton’s tyrosine kinase…
If your formulation plant is an asset, WHO-GMP vs USFDA compliance is its operating manual. Choosing the wrong compliance focus (or delaying upgrades) isn’t just a budget issue — it’s a market access and reputational risk that can cost far…
DAWNZERA (donidalorsen) is an FDA-approved antisense oligonucleotide indicated for prophylaxis of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. Approved on 2025-08-21, DAWNZERA targets prekallikrein mRNA, reducing bradykinin production, the key mediator of angioedema attacks. In…