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  • Regulatory NewsRegulatory News

    Researchers Question Consistency of FDA’s Use of Surrogate Endpoints for Drug Approvals

    The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...
  • In Rare Warning Letter, FDA Hits Company for Making Unapproved Claims About Device

    The US Food and Drug Administration (FDA) this week sent a rare Warning Letter to a medical device manufacturer chiding it for promoting its product for a purpose not approved by the agency. The 26 February 2014 Warning Letter to NeoMedix Corporation references the company's Trabectome High Frequency Generator, a device cleared earlier for use with compatible electrosurgical instruments in low-power microsurgical applications for the removal, destruction and coagulation...
  • Regulatory Considerations of Glaucoma Devices Focus of FDA Meeting

    Officials from the US Food and Drug Administration (FDA) are planning to hold a workshop in October to study the use, validity and reliability of medical devices used to image glaucomas, the agency announced in a Federal Register posting . A glaucoma is a type of eye disorder that negatively affects the optic nerve, usually because of increased pressure on the nerve, which can lead to worsened vision or blindness. In recent years, imaging devices have come to defi...