• Regulatory NewsRegulatory News

    Trying to Treat or Cure a Rare Animal Disease? FDA Says it Wants to Help

    Have an idea for a new animal drug intended to help treat a rare disease in animals or an unusual creature? The US Food and Drug Administration (FDA) says it may have some funding for you. Background The money relates to a little-known regulatory designation established under the Minor Use and Minor Species Animal Health Act (MUMS Act) of 2004. Under the law, animal conditions are effectively treated as rare if they meet either of two conditions: If the condition a...
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    FDA to Put $2.5M Behind Kidney Initiative Meant to Optimize Drug Development

    US regulators say they're planning to award at least $500,000, and as much as $2.5 million, to a set of initiatives meant to improve the regulator's understanding of the effects of pharmaceutical products on the kidney. In a Federal Register notice issued on 9 June 2014, FDA said its Center for Drug Evaluation and Research (CDER) plans to award a one-year, $500,000 contract to the American Society of Nephrology (ASN) to support the regulator's Kidney Health Initi...
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    FDA to Put Almost $38 Million Behind Effort to Improve Clinical Trials

    The US Food and Drug Administration (FDA) plans to pour as much as $37.5 million into an initiative intended to improve the quality of clinical trials, the agency has announced. In a 22 May 2014 Federal Register announcement, FDA said it plans to grant the Duke Translational Medicine Institute (DTMI) $7,500,000 per year for as many as five years in the hopes that  the "clinical trial enterprise" can be improved to better provide regulators and industry with data to dri...
  • FDA Announces $14 Million in Grants for Trials in Support of Rare Disease Therapies

    The US Food and Drug Administration (FDA) is often seen as a reactive entity-reacting, that is, to the information contained within applications in order to render an approval decision, or to postmarketing adverse event data to determine if a product remains safe for use. But as it illustrated in an announcement made on 21 October 2013, it can also be proactive when it needs to be. FDA said it will be issuing 21 grants through its Orphan Products Grants Program with the...
  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start

    A fund established under the Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007 is beginning to ramp up activity after several years of cash-strapped stagnation, but not everyone is happy about the move, reports National Public Radio (NPR) . The Reagan-Udall Foundation was created under FDAAA to create an outlet for FDA, industry, academia and patient groups to come together to fund mutually beneficial activities. "The idea was that this foundation c...