The U.S. Food and Drug Administration has published for comment its draft Guidance for Industry Endocrine Disruption Potential of Drugs: Nonclinical Evaluation. According to the FDA, “This draft guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation and Research (CDER) regarding nonclinical studies intended to identify the potential for a drug to disrupt the endocrine system. The guidance discusses factors that should be considered when determining the nature and extent of nonclinical studies necessary to characterize potential endocrine disruptor properties of drugs.” This FDA guidance on endocrine disruption testing does not mention EPA’s EDSP program. The FDA asks for comments on this draft guidance by November 19, 2013.
The NAS/NRC will hold its second meeting to review EPA’s draft paper State of the Science on Nonmonotonic Dose Response on September 30 to October 1, 2013, at the Keck Center, 500 5th Street, NW, Washington, D.C. This meeting will not be open to the public. A closed session summary will be posted on the NAS/NRC website after the meeting. The EDSP has been a frequent topic of comments so far in this review.
The CRE website was attacked with the result that had we not pulled down the website we would have risked loosing content.
We appreciate your many emails and we are working to continue to install state of the art early warning systems. We must , however, add that we have only had two major outages in more than a decade of operation.
We are particularly concerned that some of you could not use the website for the preparation of regulatory filings.
Two Science Advisory Panels have criticized EPA’s use of the Amphibian Metamorphosis Test as part of EPA’s Tier 1 EDSP screening battery. A May SAP recommended that EPA not use the AMA for any additional chemicals because its test results to date have too many problems and flaws. A July SAP has also identified many flaws in the AMA test. Click here to read SAP meeting transcript discussion of AMA at pages 368 to 373.