LSL PHARMA GROUP SUCCESSFULLY OBTAINED U.S. FDA CERTIFICATION FOR THE MANUFACTURING OF OPHTHALMIC OINTMENTS FOR COMMERCIALIZATION IN T…

LSL PHARMA GROUP INC. (TSXV: LSL) (The "Corporation" or "LSL Pharma"), a Canadian integrated pharmaceutical company, is ...
MobiHealthNews

FDA opens applications for digital health pre-certification pilot program

The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr.
FoodNavigator-USA

Why the FDA is revisiting gluten disclosure

FDA requests information to explore whether current gluten labeling rules adequately protect consumers, with implications for ...
Canadian Manufacturing

LSL Pharma Group obtains FDA certification for manufacturing of ophthalmic ointment

The certification follows a successful FDA inspection of LSL's subsidiary Steri-Med's facility, confirming full compliance with current Good Manufacturing Practices.
MobiHealthNews

Q&A: A doctor's opinion on the FDA AI certification process

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...
Becker's Hospital Review

Senate Democrats question if FDA’s digital health pre-certification will ‘compromise public safety’

Three Democratic senators are requesting additional information about the FDA’s Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency ...
JD Supra

FDA Exercises First Use of Import Certification Authority, Establishing New Requirements to Import Shrimp and Spices from Certain Regions in Indonesia

On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced that it will begin requiring import certifications for shrimp and all spices from certain regions of Indonesia based on the ...
JD Supra

First Appearance of FDA’s Import Certification Authority

The U.S. Food and Drug Administration (FDA) has instituted an import certification requirement for shrimp and spices originating from a specific region of Indonesia. This action follows the detection ...
Morningstar

FDA to Require Certification on Shrimp, Spices After Radioactive Contamination

The Food and Drug Administration said Friday it will now require import certification for shrimp and spices from certain regions of Indonesia following a bout of shrimp recalls related to radioactive ...

BrainCheck Achieves HITRUST i1 Certification, Demonstrating Commitment to Cybersecurity and Information Protection

HITRUST Certification validates that BrainCheck is meeting rigorous cybersecurity and data protection standards through ...
Morningstar

BD Receives FDA 510(k) Clearance and CE-IVDR Certification for High-Throughput Enteric Bacterial Panels on BD COR™ System

GI infections cause billions of illnesses and more than 1.7 million deaths globally each year, disproportionately affecting young children, older adults, and immunocompromised peoplei. In the United ...
WRBL

China Top Frozen Food Pouches Gain FDA Certification From Yinshili Packaging

FDA certification is especially important for the company's China top Frozen Food Pouches. These pouches have been designed to withstand the extreme conditions of freezing, thawing, and moisture while ...