Zdrowie i gospodarka · 20/05/1999

Draft ``Guidance for Industry: For Platelet Testing and Evaluation of Platelet Substitute Products;'' Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Guidance for Industry: For Platelet Testing and Evaluation of Platelet Substitute Products.'' Recent technological advances regarding platelet physiology and biochemistry have altered the way that platelets can be evaluated. The draft guidance document, when finalized, is intended to provide manufacturers with updated guidance on the evaluation of platelets and of their substituted products.