RAPS

Electronic device submissions addressed in FDA guidance

A new final guidance from the US Food and Drug Administration (FDA) lays the framework for electronic submissions for medical devices. The agency advised that more specifics about the nuts and bolts ...
Business Wire

Applied StemCell Announces Drug Master File Submission to the US FDA for their GMP-Grade iPSC Cell Line

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II ...
Morningstar

NorthStar Secures FDA Acceptance of Drug Master File for No-Carrier-Added Actinium-225

FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...
Nasdaq

FDA Accepts Tasly's Device Master File, Setting First Quality Control Standard For MSCs

(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality ...
RAPS

Electronic Device Submissions: FDA Drafts Guidance

Thanks to the FDA Reauthorization Act of 2017 (FDARA), the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to ...