Search Results for HCT/Ps

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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

CBER Calls on HCT/P Manufacturers to Report Adverse Events Within 15 Days By Zachary Brennan - Published 08 March 2016

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases.

Categories: News, US, CBER, Biologics and biotechnology, Blood, Crisis management, Human cell and tissue, Postmarket surveillance

Tags: HCT/Ps, adverse event reporting, vascular graft, amniotic membrane

FDA’s CBER Questions US Transplant Technology Company By Zachary Brennan - Published 06 November 2015

The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics.

Categories: Biologics and biotechnology, Compliance, Crisis management, Government affairs, Human cell and tissue, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CBER, HCT/Ps, tissue products, Pinnacle Transplant Technologies, cell transplants

Anvisa Unveils New Adverse Event Database By Louise Zornoza, RegLink - Published 09 December 2013

Categories: Anvisa, Blood

Tags: HCT/Ps, Adverse Event, Blood Products, brazil

India Establishes Advisory Committee for Stem Cell Products and Cell-Based Therapies By Louise Zornoza, RegLink - Published 10 June 2013

Categories: Regulatory Update, India, CDSCO

Tags: MOHW, HCT/Ps, stem cells, cells

Warning Letter to Fertility Clinic a Crash Course in Tissue Donation Ethics By Alexander Gaffney, RF News Editor - Published 08 May 2013

Categories: US, FDA, Ethics

Tags: Tissue Donation, HCT/Ps, warning letter, Latest News, disease

Average Time FDA Takes to Conduct HCT/P Facility Inspections on the Rise By Alexander Gaffney, RF News Editor - Published 05 February 2013

Categories: FDA, Blood

Tags: Tissue, HCT/Ps

Stem Cell Processor, IRB Targets of Related Warning Letters from FDA By Alexander Gaffney, RF News Editor - Published 17 October 2012

Categories: FDA

Tags: CellTex, Regenerative Sciences, 483, HCT/Ps, warning letter, Court, IRB, Latest News, stem cells, regulation

Australia Planning Updated GMPs for Blood and Tissue Products By Alexander Gaffney - Published 11 September 2012

Categories: TGA, Blood

Tags: Tissue, Donor, HCT/Ps, Blood Products, Latest News, australia, GMPs

Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority By Alexander Gaffney - Published 09 August 2012

Categories: FDA

Tags: Regenerative Sciences, HCT/Ps, Court, Latest News, stem cells, regulation

FDA Warning Letter Cites Company for Breaking HCT/P Regulations By Alexander Gaffney - Published 02 May 2012

Categories: Manufacturing

Tags: 21 CFR 1271, 483, HCT/Ps, HCT/P, HCT, warning letter, Deficiencies, Latest News, biologic