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  • Regulatory NewsRegulatory News

    Pharmaceutical Companies Look to Create Better Compassionate Use Process

    • 11 December 2014
    The prominent US pharmaceutical trade group PhRMA has released an updated set of principles it says reflects the US pharmaceutical industry's "commitment" to provide patients with life-threatening diseases access to investigational therapies on a compassionate-use basis. Background The policy is meant to accommodate patients who are otherwise not eligible to participate in a clinical trial for a new drug, either because they are too sick to participate, have a disqualif...
  • Regulatory NewsRegulatory News

    Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

    • 28 August 2014
    Earlier this year, the US Food and Drug Administration (FDA) released a much-anticipated draft guidance document which could potentially expand the ways in which pharmaceutical and medical device companies could distribute information regarding the safety of their products, even if that information isn't for an FDA-approved indication. Now the US pharmaceutical industry's largest group, PhRMA, is weighing in on the guidance, giving it rare praise for what it calls the gu...
  • Regulatory NewsRegulatory News

    FDA Releases PhRMA Proposal on How Drug Names Could be Reserved Prior to Launch

    US regulators have finally released the text of a 2009 industry proposal that is set to form the basis of discussion at an upcoming meeting on whether companies should be allowed to "reserve" drug names for late-stage investigational drugs. Background As Focus reported in July 2014, FDA recently issued a notice indicating that it was exploring allowing companies to reserve drug names. Because drug names are dispensed on a first-come, first-served basis, companies ...
  • Regulatory NewsRegulatory News

    On the Heels of FDA Investments, PhRMA Funds Regulatory Science Initiative

    In recent years, the US Food and Drug Administration (FDA) has made substantial investments in regulatory science initiatives, spending millions on research, establishing new academic programs, and partnering with dozens of institutions in the pursuit of new ways to bring safe and effective drugs to market more quickly. But the agency isn't the only one interested in advancing regulatory science. In an announcement this week, the influential pharmaceutical industr...
  • Regulatory NewsRegulatory News

    PhRMA: Recommended Language in FDA Accelerated Drug Labeling Guidance Misleading

    Pharmaceutical industry trade group PhRMA has come out forcefully against language contained within a draft guidance document issued in March 2014 by the US Food and Drug Administration (FDA), calling the agency's take on labeling drugs granted accelerated approval potentially confusing to patients and undercutting faith in the regulatory system. Background FDA's  accelerated approval pathway  is one of several tools used to expedite the approval of medicines inte...
  • PhRMA, BIO Express Unanimous Concerns About FDA Electronic Submission Guidance Docs

    Two of the pharmaceutical industry's largest trade groups are weighing in on the US Food and Drug Administration's (FDA) proposal to digitize the drug application submission process, saying the agency is generally on-point, but needs to clarify a few outstanding issues. Background In 2012, the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) was passed into law, and with it a provision mandating that all applications submitted under Section 5...
  • Regulators, Industry Prepare to Dig into Liver Toxicity Concerns in Bid to Improve Safety

    A meeting proposed by US regulators would again seek to bring together the US Food and Drug Administration (FDA), pharmaceutical trade industry group PhRMA, the regulatory science-focused Critical Path Institute and public stakeholders to discuss best practices for detecting and assessing the likelihood that pharmaceutical products cause liver damage in patients. Background Liver toxicity, sometimes referred to as hepatotoxicity, is a serious but relatively c...
  • PhRMA to FDA: Antibiotic Guidance Focuses too Much on Superiority

    The US pharmaceutical industry says a recent guidance issued by the US Food and Drug Administration (FDA) and intended to spur the development of new antibacterial therapies relies too heavily on superiority studies, potentially undermining legitimate needs and uses for drugs in light of advancing antimicrobial resistance to existing therapies. Background The draft guidance,  Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious ...
  • Pfizer Announces Adoption of Trials Transparency Policy, Illustrating Industry-Led Effort

    • 05 December 2013
    In a major but expected change, pharmaceutical manufacturing giant Pfizer has announced that it will expand the ability of outside researchers and patients enrolled in its clinical trials to access results and other clinical data. Background Transparency advocates have for years been pushing for greater access to the data, saying outside researchers should be permitted to validate study results and dig into data to find unreported safety or efficacy issues. And for year...
  • PhRMA to FDA: Tell us How Industry can use Healthcare Economic Information

    In 1997, legislators passed into law the Food and Drug Administration Modernization Act (FDAMA) , a sweeping piece of legislation which reauthorized the Prescription Drug User Fee Act (PDUFA) , overhauled the regulation of biological products, created an exemption for pharmaceutical compounding, and instituted new exemptions for some medical devices. But 15 years after the law was enacted, one provision stands out not for its impact, but for its lack of progress. Back...
  • PhRMA Launches Patient-Focused Drug Development Initiative in Hopes of Influencing FDA

    Patient-focused drug development has caught the attention of both US legislators and regulators in recent years, with the former instructing the latter to make it a part of the US Food and Drug Administration's (FDA) assessment process. And while FDA is still in the midst of setting up meetings, asking questions of patients and-crucially-figuring out how to incorporate their views into regulators' benefit-risk paradigms, a prominent member of the pharmaceutical industry h...
  • PhRMA: 'Butterfly Effect' of Poor Legislative Policy Affecting Regulations, Patients

    The US Pharmaceutical industry's standard-bearer, the Pharmaceutical Research and Manufacturers of America (PhRMA), is publicly expressing deep concern about the "significant impact" of budget cuts and furloughs on the ability of the US Food and Drug Administration (FDA) to do its job. In an opinion piece authored this week in Politico , PhRMA President John Castellani wrote that, "We in the biopharmaceutical sector are deeply concerned about the significant impact of...