• Regulatory NewsRegulatory News

    Pathology Peer Review in Toxicology Studies: FDA Offers Q&A

    The US Food and Drug Administration (FDA) on Wednesday released nine draft questions and answers to help sponsors and nonclinical laboratory staff manage and conduct pathology peer review during good laboratory practice (GLP)-compliant toxicology studies. “When conducted, pathology peer review should be well-documented. However, documentation practices during pathology peer review have not been clearly defined and vary among nonclinical testing facilities. This question...
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    FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities

    The US Food and Drug Administration’s (FDA) Toxicology Working Group this week laid out a six-part roadmap to help the agency better evaluate new methodologies and technologies for their potential to expand FDA’s toxicology predictive capabilities and to potentially reduce the use of animal testing. "Acceptance of any new toxicology methods will require sufficient convincing data as well as continuous dialogue and feedback among all relevant stakeholders from deve...
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    India’s CDSCO Offers Four New Updates to Promote Clinical Research

    India’s Central Drugs Standard Control Organization (CDSCO) issued four new circulars on Tuesday that all seek to help promote clinical research on the subcontinent. The new circulars come as pharmaceutical research in India has been on the decline in recent years. CDSCO approved 19 trials through the first four months of 2015, which compares with 76 trials approved through the first five months of 2014, and 24 approved over the same time in 2013. Academic Research ...
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    FDA Considers New Approach Toward Regulation of Dietary Supplements

    When you think of the word "book," chances are good it conjures of images of libraries and well-worn tomes. But at the US Food and Drug Administration (FDA), the word is more often associated with several databases used to keep track of critical information about the products regulated by the agency. Its "Orange Book," for example, keeps track of information regarding which products are bioequivalent to other drugs, while its newly launched Purple Book is set to do the sa...
  • With Eye to Regulatory Science, Toxicology Program Seeks Lists of Genes to Bolster Safety

    The US Food and Drug Administration (FDA) is widely recognized as the country's chief federal regulator of healthcare products, including pharmaceuticals, medical devices and 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. Now the NTP is announcing its intent to identify and prioritize a...
  • 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...
  • Toxicology Program to Assess Chemotherapy Products Used During Pregnancy

    • 15 August 2012
    The National Toxicology Program (NTP), a joint program among several federal agencies that works to assess the toxicological profiles of many chemicals, has announced a meeting to review a draft monograph on the effects of chemotherapy administered during pregnancy. NTP said it estimates between 1 in 6000 and 1 in 1000 pregnant women will need to undergo chemotherapy during the course of a pregnancy, and noted "nearly all" chemotherapy agents are toxic to the developme...
  • 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 (...
  • Government Looks to Regulatory Science to Reduce Dependence on Animals in Preclinical Testing

    • 13 June 2012
    The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies. In a report released for public comment in May 2012, DHHS, working with more than a dozen other federal agencies known as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), said better methods are needed to assess the benefits and...
  • FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products

    • 20 April 2012
    The US Food and Drug Administration (FDA) has issued new draft guidance pertaining to the inclusion of nanomaterials in cosmetic products. The draft guidance, Safety of Nanomaterials in Cosmetic Products, was released 20 April and discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products. "Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured ...
  • FDA Proposes New Regulations for Unapproved Animal Drug Residues in Imported Food

    The US Food and Drug Administration (FDA) released a new proposed regulation on Wednesday, 25 January that aims to provide a stable pathway for persons requesting the import of food items containing residues of animal drugs that are unapproved in the US. The proposed regulation -  Import Tolerances for Residues of Unapproved New Animal Drugs in Food   - is the final outstanding action FDA needs to take to fully implement the Animal Drug Availability Act of 1...