Unlocking Flexibility: FDA’s 2025 Guidance on pH Adjuster Waivers for Complex Generics
Introduction The guidance addresses how generic-drug applicants (via an Abbreviated New Drug Application, ANDA) may request a waiver under 21 CFR 314.99(b) of the…
Read more →Elevidys Gene Therapy Under Stricter FDA Controls After Fatal Liver Injury Reports
1. Background on Elevidys 2. Trigger for Regulatory Action 3. Nature of the FDA Action (Labeling & Indication Revision) On November 14, 2025, the…
Read more →How to Prepare a Pre-Request for Designation (Pre-RFD)
Introduction The FDA’s guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)” provides structured recommendations for sponsors seeking preliminary feedback from the Office of…
Read more →Depth Article: Revisiting Hormone Replacement Therapy — A Paradigm Shift in Women’s Health
1. Background: What Changed The U.S. Food & Drug Administration (FDA), in coordination with the U.S. Department of Health & Human Services (HHS), has…
Read more →Important Update for Healthcare Professionals: Opella Healthcare France
On 24 October 2025, the pharmaceutical company Opella Healthcare France S.A.S. (on behalf of the product) issued a letter to healthcare professionals notifying of…
Read more →Safeguarding Children’s Oral Health: A New Chapter by the U.S. Food and Drug Administration
What’s Happening? On October 31, 2025, the FDA issued a landmark announcement titled “U.S. Food and Drug Administration Acts to Protect Children from Unapproved…
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