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It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.
India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders.
The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in the development of FDA-approved new molecular entities and new biologics.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.
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The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs. View More
The US Food and Drug Administration (FDA) has agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications for renal cell carcinoma, metastatic melanoma and non-small cell lung cancer. View More
The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said will result in “rapid increases” in the percentage of trials registered and shared via ClinicalTrials.gov, though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. View More
The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each first new biosimilar for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application. View More