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  • Regulatory NewsRegulatory News

    GAO: Retail Drug Price Expenditures Have Nearly Doubled Since 1990s

    The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs. Retail prescription drug expenditures were estimated to account for about 12% of total personal health care service spending in the US in 2015, up from abou...
  • Regulatory NewsRegulatory News

    FDA Hedges: A Proposal to Better Share R&D Risks

    The probability that an investigational drug will succeed in all three phases of clinical trials and win US Food and Drug Administration (FDA) approval is very low. So low, in fact, that a group of economists have written a new paper calling for a system whereby developers could hedge their research and development (R&D) risks by buying options that would pay companies a pre-specified amount in the event that a treatment fails a given phase of the FDA approval proce...
  • Regulatory NewsRegulatory News

    Updated: Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts

    With the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change. On Monday, Public Citizen released a new report  [ Editor's note: This report has since been retracted by Public Citizen due to methodological issues ] trying to dispel the pharmaceutical industry’s allegations that high drug prices are unavoidable bec...
  • Regulatory NewsRegulatory News

    22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report

    With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA) on Thursday released a new report documenting 22 different times drugs, vaccines and medical devices since 1999 saw promising Phase 2 clinical trial results that were not confirmed in Phase 3 trials. FDA says the report “is not intended to assess why each of these unexpect...
  • Regulatory NewsRegulatory News

    Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices

    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. The call for more compulsory license...
  • Feature ArticlesFeature Articles

    Looking to the Future in Regulatory Affairs

    Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and expectations, and discussions with peers in the regulatory community. There are many strands to consider when looking to the future in regulatory affairs. The first strand is the regulations and how these are likely to be impacted by a globalized ...
  • Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part 2

    The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews. Consider a Pre-Submission Meeting One particular strategy we have found quite productive, particularly for more-complex or innovative devices, is to...
  • Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part I

    In recent months, I have attended various medical conferences and trade shows that have highlighted many of the most promising med-tech innovations. From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. Yet, as a regulatory professional, I was struck by the numerous calls for the US Food and Drug Administration (FDA) reform and the claims FDA is st...
  • Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting

    The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve industry efficiency when conducting such trials. "The feedback may increase communication and collaboration within the stakeholder community, and, ultimately, help overcome some of the current challenges associated with designing clinical studies and generating clinical per...
  • Report: FDA Increasingly Playing Key Role in Global Health

    A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration's (FDA) effects are being felt far beyond US borders. The US health regulatory agency's statutory mandate is ostensibly to ensure the safety and effectiveness of products used by American consumers, but it is "increasingly…playing a role in global health R&D,...
  • For Terminally Ill Patients, 'Life Spans Shorter Than FDA's Approval Process' Spurs DIY Medicine

    Some terminally ill patients are turning research and development into a DIY enterprise, frustrated at the pace of getting potentially life-saving treatments through the US Food and Drug Administration (FDA), reports The Wall Street Journal . "We simply don't have time to wait for the results of [clinical trials]," said Ben Harris, who suffers from Lou Gehrig's Disease (ALS), to the Journal . "Our life spans are much shorter than the [Food and Drug Administration] appr...