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  • Feature ArticlesFeature Articles

    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
  • Regulatory NewsRegulatory News

    CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices

    A little more than a year since the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) put the finishing touches on a new expedited review process for potentially life-saving medical devices and the agency has accepted almost 60% of the applications of those looking to be a part of the new program. Over the past year, CDRH has made 29 decisions on requests for designation into its voluntary Expedited Access Pathway (EAP) program, an...
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    Physicians Lack Understanding of What ‘Breakthrough’ Designation Means, Study Finds

    A US survey of board-certified internists and specialists revealed “substantial deficits in knowledge” of what it means for a drug to be approved by the US Food and Drug Administration (FDA) and approved via the “breakthrough” pathway, according to a research letter published in JAMA on Tuesday. Since 2012, FDA has designated certain drugs as "breakthrough” therapies (76 drugs have received the designation through April 2015) if preliminary clinical evidence – such as ...
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    FDA Review Times Steadily Decreasing, Report Finds

    Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...
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    Analysis: Breakthrough Therapies Cut Development Timeline by Two Years

    A nonprofit cancer advocacy group says that the US Food and Drug Administration's (FDA) breakthrough therapy designation has been effective in shortening the amount of time it takes to develop new oncology drugs by more than two years. In a paper published in The Pharmacogenomics Journal in March, the authors from the Friends of Cancer Research say that cancer drugs with breakthrough therapy designations also see faster approval times than non-breakthrough products as ...
  • Regulatory NewsRegulatory News

    First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA

    Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options. The total of 45 approvals was well ahead of FDA’s average of about 28 novel approvals between 2006 and 2014, and 36% of those new approvals were for first-in-class drugs while almost half (47%) were to treat rare diseases, or ailments that impact 200,000 or...
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    What Causes Variations in Review at CDER? It's All About the Designation

    Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas. The MIPR study concluded that the variations in rev...
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    Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices

    Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way. Background On 24 April 2015, Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced the Advancing Breakthrough Devices for Patients Act ( ABDP Act ) . As written, the law is heavily based on the "breakthrough therapies" section ( Section 902 ) of th...
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    Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The US now is reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. 1 This trend is due in part to FDA’s ongoing commitment to improve the drug development process and establish robust, efficient and predictable development programs. As a result, products demonstrating a positive benefit-risk profile and appropriate e...
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    FDA’s Expedited Programs for Serious Conditions: An Overview

    For some serious or life-threatening diseases, few therapeutic options exist. Once a promising therapy is discovered, establishing its clinical benefit and safety profile is necessary but can be time consuming. Standard drug development programs involve formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on its performance, evaluating the safety risks and confirming the effects observed in the early clinical trial...
  • Regulatory NewsRegulatory News

    FDA Finalizes Expedited Product Guidance With Hundreds of Major, Minor Changes

    The US Food and Drug Administration (FDA) has finalized its long sought-after guidance document on the use of its four expedited drug approval programs, including the recently instituted breakthrough product designation. Background FDA released the draft expedited programs guidance, Expedited Programs for Serious Conditions—Drugs and Biologics , in June 2013. In the draft, FDA outlined how it says it planned to use four tools at its disposal designed to expedite ...
  • Regulatory NewsRegulatory News

    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...