Search Results for FDA final guidance

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FDA Finalizes Guidance on Deviation Reporting for HCT/Ps By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue

Tags: HCT/Ps, human tissues, FDA final guidance

FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems Published 07 October 2016

The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users.  

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: blood glucose monitoring, FDA final guidance, glucose monitoring systems

GPhA Questions Legality of FDA Guidance on Physical Attributes of Generic Drugs By Zachary Brennan - Published 14 September 2015

The Generic Pharmaceutical Association (GPhA) is raising a number of concerns, among them the legality, of the US Food and Drug Administration's (FDA) recently issued final guidance on the size, shape and other physical attributes of generic drugs.

Categories: News, US, FDA, Compliance, Generic drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: GPhA, FDA guidance, generic drugs, physical attributes of generic drugs, FDA final guidance