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  • Regulatory NewsRegulatory News

    Genomic Data and Drug Development: EMA Offers New Draft Guidance

    As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses. The aim of the guidance, according to EMA, is to lay out the requirements related to the choice of appropriate genomic methodologies during the development and lifecycle of a drug. Background Pharmacogenomics research...
  • Regulatory NewsRegulatory News

    FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs

    The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for their abbreviated new drug applications (ANDAs). The list targets what trials should be run by those developing a number of new generic oncology treatments, though many have yet to lose patent protection and some were recently approved, including Pfizer’s breast cancer drug Ibra...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (31 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Cardiovascular Working Party Signs off on Final Reflection Paper, Guidelines The Committee for Medicinal Products for Human Use (CHMP) has adopted a pair of final regulatory documents created by the Cardiovascular Working Party (CWP). Most significantly, the committee has adopted final guidelines on clinical trials of treatments for venous thromboembolism (VTE). Having bee...
  • Regulatory NewsRegulatory News

    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
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    EMA Offers Updated Draft Guidance on Human Clinical Trials for Cancer Drugs

    The European Medicines Agency (EMA) on Tuesday published new draft guidance on the evaluation of anticancer medicines in humans that covers all stages of clinical development. The guidance, which is available for comment through 15 September, delves into the development of treatments for malignancies, including “drug resistance modifiers or normal tissue protective compounds.” A very large number of anti-cancer compounds are being developed, EMA notes, though only a min...
  • Regulatory NewsRegulatory News

    Gilead Halts Six Cancer Trials as EMA, FDA Warn of Increased Adverse Events

    Biotech juggernaut Gilead Sciences is halting six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas after an increased rate of serious adverse events, including deaths, mostly due to infections. The US Food and Drug Administration (FDA) late Monday issued an alert to health professionals of the stoppages, noting that they should be aware that the cancer medicine Zydelig (idelalisib) is not approve...
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    Precision Medicine: Technology, Regulations and Challenges

    • 11 March 2016
    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Feature ArticlesFeature Articles

    Precision Medicine: Technology, Regulations and Challenges

    This article discusses fundamentals of precision medicine, providing an update on how recent regulations and technology trends are contributing to the advancement of patient-centered healthcare. As the field of Precision Medicine (PM) continues to escalate on the trajectory from hypothesis-driven conception to customary clinical best practice, there are facets impacting not only commercial product developers, but also select general public subgroups in dire need of ind...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines The European Medicines Agency (EMA) has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it ...
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    Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

    President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...
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    Asia Regulatory Roundup: India Taxes Cancer, HIV Drug Imports (9 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...
  • Regulatory NewsRegulatory News

    Billion-Dollar Cancer ‘Moonshot’ Plan Includes $75M in New Funds for FDA

    The White House’s $1 billion proposal to fund Vice President Joe Biden's “Moonshot” cancer initiative also includes several proposed investments in federal agencies, including $75 million for a new center at the US Food and Drug Administration (FDA). President Barack Obama’s State of the Union address singled out Biden as the leader of the expansive initiative that so far has few details, and which has raised some serious doubts from cancer researcher Vinay Prasad (who...