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  • Regulatory NewsRegulatory News

    FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

    A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks. According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also impro...
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    FDA Approves First DTC Tests Evaluating Genetic Risk Information

    The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer (DTC) genetic health risk tests for 10 diseases and conditions. The authorization for the genetic testing company 23andMe means individuals for the first time will be able to use these tests to understand their genetic predispositions for certain diseases and conditions without first seeing a doctor. “Consumers can now have direct access to certain genetic risk information,”...
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    Small Biopharma Face Distinct Challenges: FDA Official and Sanofi Genzyme SVP Argue

    Small biopharmaceutical companies, often known as the drivers of innovation, face a number of unique challenges in bringing new treatments, particularly for rare diseases, to market, Richard Moscicki, deputy director for science operations at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, and P.K. Tandon, senior vice president of Sanofi Genzyme, wrote. In an article published Tuesday in the New England Journal of Medicine , the a...
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    FDA Further Explains Delay on LDT Guidance

    Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward. As FDA explains, “LDTs play an increasingly important role in the provision of high-quality health care and many laboratories perform good validation of their LDTs and provide high...
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    FDA Delays Finalization of Lab-Developed Test Draft Guidance

    The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated. Tara Goodin, press officer for FDA told Focus : "FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been...
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    FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics

    The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic. The draft released Thursday, entitled "Principles for Codevelopment of an...
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    Regulating Precision Medicine: Capacity vs. Overreach

    As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine. In an article published online this week in the Journal of Law and the Biosciences , titled “Precision medicine: drowning in a regulatory soup?” a group of mostly Australian researchers note that...
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    DTC Drug Advertising: FDA to Launch First Public Survey Since 2002

    Direct-to-consumer (DTC) advertising for pharmaceuticals has been a hot topic recently as federal and state officials have questioned their utility, particularly as the US and New Zealand are the only two countries in the world that have them. Now, the US Food and Drug Administration (FDA) is looking to survey patients about their experiences with DTC drug ads. The survey will question respondents about their knowledge of FDA's authority over prescription drug advertisi...
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    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
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    Two More Companies Questioned by FDA Over DTC Genetic Tests

    The US Food and Drug Administration (FDA) sent letters to two genetic testing companies for marketing direct-to-consumer pharmacogenetics tests. The letters, addressed to Healthspek and Genomic Express, claim that tests sold through the companies' websites meet the definition of a medical device and must be cleared by FDA before being marketed. FDA Letters to Genetic Testing Companies Company Test Name Indication or Claim Genomic Express  Clopidogrel (Pl...
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    FDA Raises Questions Over DTC Genetic Tests Offered at Rite Aid

    The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid. According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if the...
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    FDA Defends Plans to Regulate LDTs at House Hearing

    The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs). Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests." Unlike traditi...