• 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    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the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...
  • Feature ArticlesFeature Articles

    Can Rodent Carcinogenicity Testing Be Eliminated?

    The International Conference on Harmonisation (ICH) Steering Committee has endorsed a concept paper that supports reviewing and harmonizing requirements for carcinogenicity testing in rodents (Topic S1). 1 In line with the 3Rs principle (reduction, replacement and refinement - a major principle of the ICH harmonisation process), the paper suggests it may be possible to reduce or eliminate the need for such testing in a significant number of cases. Such an outcome could ...
  • European Commission: Non-EU Reference Product OK for EU Biosimilars

    The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a  speech  delivered by Health and Consumer Policy Commissioner Dalli at the 18thEuropean Generic Medicines Association Annual Conference. Dalli announced "that after careful analysis of the scientific and regulatory elements, the European Commission will revise its interpretation" of existing EU law. The details o...
  • NIH Drug Development Acceleration Program Expands to Include New Members

    A program launched by the National Institutes of Health (NIH) to repurpose existing advanced-stage drug compounds by partnering with pharmaceutical manufacturers has expanded to more than double its existing membership, the NIH announced on 12 June. The initiative, known as the Discovering New Therapeutic Uses for Existing Molecules program, was founded in May 2012 by the newly-formed National Center for Advancing Translational Sciences (NCATS) to take the existing com...
  • FDA Releases Final ICH Guidance on Genotoxicity Testing and Data Interpretation

    The US Food and Drug Administration (FDA) announced it has released new, harmonized guidance for sponsors looking to conduct genotoxicity testing and data interpretation for human drug products. The guidance, originally put forth in 2008 by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), combines and replaces two existing ICH guidance documents: S2A Specific Aspects for Regulatory Genotoxic...
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    A Conversation With FDA's Human Factors and Accessible Medical Technology Expert

    The US Food and Drug Administration (FDA) released its Draft Guidance for Industry and Food and Drug Administration Staff-Applying Human Factors and Usability Engineering to Medical Devices to Optimize Medical Device Design on 22 June 2011. According to this document medical device manufacturers must perform appropriate human factors engineering and usability testing on their products. To help device makers and regulatory professionals working with devices better under...