FDA Safety Labeling Changes for ACTEMRA (tocilizumab): What Changed, PV & Regulatory Impact, and a Playbook for Shudarsana
What changed in the U.S. label Newest update (August 8, 2025): Recent prior update (September 2024): Practical takeaway: Two concurrent risk domains now shape…
Read more →Recent Safety Labeling Changes for BYOOVIZ
On August 15, 2025, the FDA approved safety-related labeling changes for BYOOVIZ (ranibizumab-nuna, BLA-761202) FDA Access Data. Key updates include: Impact on Pharmacovigilance Processes…
Read more →Ensuring Patient Safety: FDA’s Draft Guidance on Assessing Overall Survival in Oncology Clinical Trials — A Multi-Perspective Analysis
Article 1. Regulatory Perspective The FDA’s August 2025 draft guidance outlines recommendations for evaluating Overall Survival (OS) in randomized oncology trials, particularly when OS…
Read more →Empowering Safe Innovation: FDA’s Predetermined Change Control Plan (PCCP) Guidance for AI-Enabled Medical Device Software Functions – A Regulatory, Pharmacovigilance, MAH, and Impact Perspective
1. Regulatory Perspective In April 2023, the FDA issued draft guidance introducing the Predetermined Change Control Plan (PCCP) framework. Its goal: to enable AI/ML-enabled…
Read more →FDA warns against unapproved epinephrine nasal solutions from BPI Labs & Endo USA: what happened, why it matters, and what to do now
Key takeaways What the FDA alert actually says On Jan 16, 2025, the FDA told health care professionals not to use unapproved epinephrine nasal…
Read more →FDA Warning Letter to Vacation, Inc. (Aug 6, 2025): What Happened, Why It Matters, and What Comes Next
On August 6, 2025, the FDA issued a Warning Letter to Vacation, Inc. over its “Classic Whip” sunscreens sold in mousse/whipped-cream style canisters. The…
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