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  • Regulatory NewsRegulatory News

    AMA Calls to Ban DTC Advertising for Drugs, Medical Devices

    Physicians at the American Medical Association (AMA) on Tuesday called to ban direct-to-consumer (DTC) advertising for drugs and devices because of the negative impact of the commercially driven promotions. Physicians revealed concerns that the increase of ads in the US (only the US and New Zealand allow DTC advertising for drugs and devices) is driving demand for newer, more expensive treatments even though less-costly alternatives may be more effective. AMA Board Chai...
  • Regulatory NewsRegulatory News

    FDA Warns Three Companies Over DTC Genetic Tests

    Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared. In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnost...
  • Regulatory NewsRegulatory News

    FDA Proposes to Exempt Some Genetic Screening Systems from Premarket Requirements

    The US Food and Drug Administration (FDA) has decided to look into exempting from premarket requirements some genetic screening systems that can test parents for specific conditions they could possibly pass down to their children. The possible exemption of the autosomal recessive carrier screening gene mutation detection systems, which are Class II devices, would help companies bring to market systems that can test parents for specific genetic conditions, such as cy...
  • Regulatory NewsRegulatory News

    House Committee Floats Draft Bill for New FDA Regulations of In Vitro Clinical Tests

    In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests. The 185-page draft bill lays out how it would create a new Center for In Vitro Clinical Tests within the US Food and Drug Administration (FDA). And although the bill refers to the tests as "in vitro clinical tests," it remains to be seen how FDA would regulate the tests differently from  in ...
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    FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads

    As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...
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    FDA Finalizes Guidance on Donor Screening for Syphilis Infection

    The US Food and Drug Administration (FDA) has finalized its guidance to establishments that screen human tissue and cell donors for various communicable diseases on screening for Treponema pallidum , commonly known as syphilis. Background Under 21 CFR 1271.80 , establishments that screen donors of human cells, tissues and cellular and tissue-based products (HCT/P establishments) are required to screen for specific diseases, such as syphilis, human immunodeficiency vi...
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    What Did You Say? FDA Plans Study on How Hearing Loss Affects Drug Ad Understanding

    The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising. Background The study, announced in a 24 June 2015 posting in the Federal Register , is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug ad...
  • Regulatory NewsRegulatory News

    FDA, CMS Teaming up to Co-Regulate Lab-Developed Tests

    • 20 April 2015
    • By
    The US Food and Drug Administration (FDA) is teaming up with the US Centers for Medicare and Medicaid Services (CMS) to better regulate lab-developed tests (LDTs), which are currently overseen—haphazardly—by both agencies. Background The move is related to FDA's efforts late last year to regulate LDTs more similarly to traditional medical devices, and in particular in vitro diagnostics (IVDS). FDA has long maintained its authority to regulate LDTs, which are tests devel...
  • Regulatory NewsRegulatory News

    UK Regulators Prepare for Review of 'Forgotten Thalidomide'

    Regulators in the UK are asking the public to report “suspected adverse effects” of hormonal pregnancy tests (HPTs), which have been off the market in the UK since the late 1970s after being associated with serious birth defects and miscarriages. The information will be used as part of an independent review to determine whether there is a causal relationship between HPT use and reported side effects. MHRA is asking for submissions by 30 June 2015, and says the repo...
  • Regulatory NewsRegulatory News

    FDA Calls for Changes to Drug Advertising in Hopes of Increasing Patient Understanding

    The pharmaceutical advertising you see in magazines and newspapers will soon include less information in the hopes of better conveying what the actual risk of the drug is, the US Food and Drug Administration (FDA) announced today. Background The change represents a substantial shift in policy for the agency, which has traditionally favored the inclusion of as much risk information as possible in its advertising. For example, FDA's Office of Prescription Drug Promotion (...
  • Regulatory NewsRegulatory News

    Top Legal Minds Against FDA's Proposal to Regulate Lab Tests

    A new legal whitepaper authored by two of America's most prominent lawyers argues that the US Food and Drug Administration's (FDA) plan to regulate lab developed tests (LDTs) more similarly to traditional medical devices lacks legal justification and is therefore unlawful. For more on LDTs and why and how FDA wants to regulate them, please see our August 2014 explanation of the policy shift here. The legal analysis is co-authored by  Paul Clement, the former US ...
  • Regulatory NewsRegulatory News

    FDA Releases New Recommendations to Ensure Drugs Don't Cause Car Accidents

    US regulators have released new recommendations for manufacturers of psychoactive drugs—including sleep aids—following several warnings by the US Food and Drug Administration (FDA) that some drugs were causing patients to get into car accidents hours after the effects of the drug should have worn off. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond atypically,...