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  • New Guidance Aims to Reduce Medication Errors Through Better Preapproval Testing

    The US Food and Drug Administration (FDA) has published a new draft guidance on ways to minimize medication errors through designing products with safety considerations in mind, part of the agency's unfinished efforts under the FDA Amendments Act (FDAAA) of 2007. The guidance , posted to FDA's website on 12 December 2012, notes that it is intended to provide sponsors of pharmaceutical and biopharmaceutical products with "a set of principles for developing drug product...
  • Regulators Say Contract Analytical Company 'Falsified' Testing

    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 Chemi Pharmaceutical, regulators announced on 4 December 2012. In a statement, Health Canada said it is in the process of "verifying the nature and use of testing done by Chemi Pharmaceutical with the company's customers." "Our survey of clients to date indicated that only a ...
  • Final Guidance for Blood Product Testing Released by FDA

    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 hopes will assist in the screening of blood and plasma donors for the virus. The final guidance comes nearly a year after the agency first released the draft version of the guidance . FDA said it considers Hepatitis B (HBV) NATs to be "necessary to reduce adequately and a...
  • NIH Initiative Hopes to Improve How Preclinical Testing is Reported

    • 11 October 2012
    The National Institutes of Health (NIH) has announced a set of consensus recommendations it says will improve the way preclinical animal studies are designed and conducted, ultimately making them easier to reproduce and understand. The problem, explains NIH, is the gap between conducting animal studies and being able to study the effect of a drug in human trials. "Positive results from animal studies are sometimes difficult to translate into successful clinical trials,...
  • New Chemical Testing Method to Reduce Reliance on Animal Eye Testing

    • 10 October 2012
    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 chemical is hazardous to the eye. The NTP and its various subprograms are responsible for bringing together more than a dozen federal agencies to generate and harmonize testing standards for toxic substances. Through its committees, it evaluates safety testing methods and strategi...
  • New Draft Stability Guidance Calls for Use of ICH Standards

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH). Abbreviated New Drug Applications (ANDAs) are commonly used to support generic drug applications under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . FDA said it ...
  • China's SFDA Issues Drug Testing Guidance

    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 implementation of goals contained within China's national 12 th Five Year Plan. The plan calls for accelerating "rapid drug testing technology research" to detect counterfeit and adulterated drug products.  The guidance explains SFDA will be responsible for organizing a nat...
  • Rules for Blood Testing, Storage Changed

    • 29 August 2012
    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 exceptions or alternatives with regard to blood, blood components or blood products. Requests for such exceptions or alternatives should be made in writing. Manufacturers can store thawed plasma at 1 to 6 degrees Celsius for up to 24 hours, according to the news report. Donors w...
  • Regulatory Bodies to Assess Alternate Vaccine Testing Methods

    • 27 July 2012
    The US Food and Drug Administration (FDA) is widely known as the country's chief federal regulator of biological products. Lesser-known-but still important-is another federal program known as the National Toxicology Program (NTP) , which works to help agencies to understand and accept the toxicological profiles of many chemicals, including those used in vaccines. The NTP's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) on Thursday (...
  • NIH Program Partners With FDA to Develop Regulatory Tools

    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 drug compounds without needing to first test them in human subjects. The project-a series of 17 grants disbursed to medical and academic centers across the country-isn't, as first reported, intended to develop just a single chip capable of analyzing all toxicities. Rather, the...
  • MHRA Releases IVD Guidance for Notified Bodies

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance for notified bodies pertaining to the regulation of in vitro diagnostic (IVD) products used in home healthcare settings for self-testing. Assuring the safe use of these products is a challenge, the agency notes, as there is unlikely to be a healthcare professional present to guide the patient in the proper use of the device or the correct interpretation of its results. "It i...
  • Presidential Commission Looking to Study Ethical Issues of Animal Rule in Pediatric Populations

    • 28 June 2012
    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, the Presidential Commission for the Study of Bioethical Issues-a commission formed in 2009 specifically to look at ethical issues related to "biomedicine and related areas of science and technology"-said it wants to look deeper into the legal, ethical and social issues o...