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Latest News | 27 February 2013

Update of Blood and Plasma Guidance Calls for Revised Syphilis Screening Procedures

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A new draft guidance published by the US Food and Drug Administration (FDA) recommends revised screening procedures to guard against the threat of syphilis contamination in donated blood and plasma, Read More...


Latest News | 19 February 2013

How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

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What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon Read More...


Latest News | 4 February 2013

FDA Releases ICH Photosafety Guidance for Industry Comment

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The US Food and Drug Administration (FDA) has released a draft guidance pertaining to a document currently under development by the International Conference on Harmonisation (ICH) that would harmonize Read More...


Latest News | 5 December 2012

Regulators Say Contract Analytical Company 'Falsified' Testing

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Canadian regulators are scrambling to re-evaluate more than 20 companies' approved and pending products after finding "falsified" testing results during the course of an inspection at Ontario-based Read More...


Latest News | 14 November 2012

Final Guidance for Blood Product Testing Released by FDA

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The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it Read More...


Latest News | 10 October 2012

New Chemical Testing Method to Reduce Reliance on Animal Eye Testing

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The National Toxicology Program (NTP) has announced a new classification criterion that it says should require between 50% and 83% fewer animals to be used during testing to determine whether a Read More...


Latest News Regulatory Update | 6 September 2012

China's SFDA Issues Drug Testing Guidance

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China’s State Food and Drug Administration (SFDA) has issued guidance to provincial and municipal food and drug agencies and the Chinese Institute of Food and Drug Testing concerning the Read More...


News Latest News | 29 August 2012

Rules for Blood Testing, Storage Changed

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The U.S. Food and Drug Administration (FDA) is changing the rules for human blood testing and storage, according to a report by in-Pharma Technologist.A new procedure issued by FDA allows for Read More...


Latest News | 24 July 2012

NIH Program Partners With FDA to Develop Regulatory Tools

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A new project funded by the National Institutes of Health (NIH) could assist regulators by allowing the US Food and Drug Administration (FDA) to develop test chips to evaluate the toxicity of novel Read More...


Latest News | 28 June 2012

Presidential Commission Looking to Study Ethical Issues of Animal Rule in Pediatric Populations

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A Presidential Commission in charge of studying bioethics wants to know: what are the ethical issues associated with studying medical countermeasures in children?In a 28 June Federal Register posting, Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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