JD Supra

A Clearer Path from FDA for ‘Minor Changes’ to Solid Oral Dosage Forms for OTC Monograph Drugs

Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while ...
Morningstar

Sonoma Pharmaceuticals Expands Market Reach with FDA Cosmetic Product Facility Registration and Microcyn-Based Cosmetic Product Listing Under MoCRA

BOULDER, COLORADO / ACCESS Newswire / October 7, 2025 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology-based stabilized ...
JD Supra

FDA Issues Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities in Pending Applications

On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...

Branded Legacy, Inc. (OTC: BLEG) Advances Life-Saving Innovation with FDA Pre-ANDA Briefing for Revolutionary Intranasal Naloxone Spray

VANCOUVER, British Columbia, Oct. 22, 2025 (GLOBE NEWSWIRE) -- via IBN -- Branded Legacy, Inc. (OTC:BLEG), a dynamic holding company focused on ...