(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 ...

The US Food and Drug Administration (FDA) has issued a draft guidance to industry that specifies where sponsors should submit “cross-center” master files (MFs) that are referenced and intended to ...

HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) ...

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and ...

TIANJIN, China, Jan. 25, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal ...

Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...