Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
Seeking Alpha

United Health Products Provides Update on FDA PMA Application Process

Mesquite, NV, March 29, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...

Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell ...

First U.S. pivotal study for Alpha Tau to have completed enrollment, representing a critical milestone on the path towards potential FDA ...
Business Wire

Allurion Passes Critical FDA Milestones, Enters Into Transaction to Exchange All Outstanding Debt That Would Result in the Company Being Debt-Free, and Announces a $5 Million ...

$5M private placement financing with participation from new and existing stockholders and a strategic partner with deep obesity expertise significantly strengthens Company’s financial position as the ...

Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
Seeking Alpha

United Health Products Submits Full FDA PMA Application

MOUNT LAUREL, NJ, March 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire-- United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. The ...

Galaxy Therapeutics Submits Final Module of PMA to U.S. FDA for SEAL™ Device in Wide-Neck Bifurcation Aneurysms

Galaxy Therapeutics, a privately held, clinical-stage medical device company focused on treating brain aneurysms, today announced the submission of its final module of its Premarket Approval (PMA) ...
RAPS

FDA Offers New Insight on When to Submit PMA Supplements for Device Manufacturer Site Changes

Medical device companies trying to understand what officially constitutes a manufacturing site change and when to submit a premarket approval (PMA) supplement will want to consult with draft guidance ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...