Search Results for toxicity

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Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs By Zachary Brennan - Published 04 December 2017

Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: cancer drugs, toxicity

Reproductive Toxicity: FDA Consults on Revised ICH Guideline By Michael Mezher - Published 09 November 2017

The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Clinical, Drugs, Preclinical

Tags: Reproductive Toxicity, ICH, S5(R3), Draft Guideline

Rodent Carcinogenicity Testing: Changes to ICH Guidance Proposed By Zachary Brennan - Published 02 March 2016

The European Medicines Agency (EMA) is considering changes to International Council for Harmonisation (ICH) guidance on rodent carcinogenicity testing to improve the evaluations, reduce use of animals and drug development resources and reduce timelines to market authorization in some cases without compromising patient safety.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, ICH, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: carcinogenicity testing, animal drug testing, pharmaceutical testing, toxicity testing, ICH

New FDA Guidance Seeks to Protect Unborn from Fathers’ Drug Toxicities By Alexander Gaffney, RAC - Published 12 June 2015

When the US Food and Drug Administration (FDA) evaluates a drug, it's not just concerned about the drug's effect on the intended patient; it's also concerned about the drug's potential effect on other patients as well.

Categories: News, US, CDER, Clinical, Drugs, Ethics

Tags: Draft Guidance, Guidance, Men, Male, Male-Mediated, Children, Toxicity, Genotoxicity

Zebrafish Touted by Regulators as Model Tool for Predicting Drug and Nanoparticle Toxicity By Alexander Gaffney, RF News Editor - Published 08 April 2013

Categories: US, FDA

Tags: Toxicity, zebrafish, regulatory

NIH Program Partners With FDA to Develop Regulatory Tools By Alexander Gaffney - Published 24 July 2012

Categories: FDA

Tags: Chip, DARPA, Toxicity, NIH, Latest News, testing, safety, regulatory

USP Releases Overhaul of Impurities Testing Standards By Alexander Gaffney - Published 24 May 2012

Tags: Purity, <233>, <231>, <232>, Impurities, Toxicity, Latest News, Excipient, Standards, USP, pharmaceutical, drug, API

Study: Benefits of Some Cancer Drugs Mitigated by Other Drugs By Alexander Gaffney - Published 16 March 2012

Categories: Drugs

Tags: Toxicity, Interactions, Pharmaceuticals, Effectiveness, Oncology, Latest News, cancer