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  • Regulatory NewsRegulatory News

    Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity

    Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity. The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the ...
  • Regulatory NewsRegulatory News

    With PDUFA VI Negotiation Process Fast Approaching, BIO Takes Critical Look at Regulations

    The Biotechnology Industry Organization (BIO), a trade group which represents biopharmaceutical companies, is launching a new tracking tool meant to assess how companies interact with the US Food and Drug Administration (FDA) in the hopes of improving the drug development process, it announced today. The survey is specifically meant to inform negotiations over the next iteration of the Prescription Drug User Fee Act (PDUFA), which was last authorized in 2012 and it...
  • 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...
  • BIO, Following PhRMA and EFPIA, Releases Clinical Trial Data Transparency Plan

    The Biotechnology Industry Organization (BIO) has announced that its member companies will soon grant wider access to clinical data, mirroring recent and similar efforts made by the pharmaceutical industry but falling short of calls made by transparency campaigners. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, largely after some companies were found to have hidden unfavorable data regardi...
  • BIO Argues Changes Needed to FDA's Drug Shortage Rule to Account for Vaccines

    Should vaccines be considered under the US Food and Drug Administration's (FDA) recent drug shortages rule? No, argues the Biotechnology Industry Organization (BIO), which explained in a recent letter to FDA that the Centers for Disease Control and Prevention (CDC) has been able to adequately handle shortages of vaccines on its own for at least the last decade. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drug...
  • Pharmaceutical Industry Experts Slam FDA's PDUFA Report, Calling it too Vague to be Useful

    The pharmaceutical and biopharmaceutical industries have long been supportive of the user fee schemes used to fund the US Food and Drug Administration (FDA). Originally passed under the Prescription Drug User Fee Act (PDUFA) in 1992 in response to the delay in approvals in drugs in the US compared to in the EU, the basic fee structure-with some added changes and conditions-has been reauthorized another four times, most recently with the passage of the Food and Drug Adm...
  • BIO, PhRMA Announce Plan to Keep Tabs on PDUFA Progress Through Tracking Database

    The Prescription Drug User Fee Act (PDUFA) is one of the single most important pieces of legislation affecting the life sciences industry, and in particular innovative pharmaceutical and biopharmaceutical companies. It is, at its most basic element, a trade-off between pharmaceutical companies and the US Food and Drug Administration (FDA). In the 1990s, an industry frustrated with the slow pace of drug approvals got together with FDA to float a proposal: If FDA would a...
  • PhRMA, BIO, GSK Call on FDA to Alter eCTD Draft Guidance

    Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance published by US regulators, saying minor changes are needed to reflect the clarity of the guidance and its lifespan. Background Their comments reference a 3 January 2013 draft revision of guidance for industry that would require all new drug applications (NDAs), abbreviate...
  • Biosimilars Guidelines Attract Attention, Criticism

    As Genetic Engineering & Biotechnology News reported in mid-April, the US Food and Drug Administration's (FDA) draft biosimilar regulations attracted mostly negative comments . Now some companies are adding further commentary to the pile-and they're bringing up points of substantial friction with FDA. Pharmaceutical manufacturer Amgen told FDA regulators that "requiring the maintenance of biosimilarity over time would inhibit manufacturing and quality improvem...
  • BIO Head Calls for New Position to be Formed at FDA to Boost Innovation

    The head of the Biotechnology Industry Organization (BIO), the leading trade group for biotechnology and biopharmaceutical organizations in the US, called on the US Food and Drug Administration (FDA) to make room in its organizational structure for a Chief Innovation Office (CIO), reports The Boston Business Journal . Speaking at the organization's annual meeting in Boston, BIO President and CEO James Greenwood said FDA has a duty to go beyond its mission to protect con...
  • BIO Analysis: Resubmissions After Third Round of FDA Review Not Worth the Effort

    An analysis by the Biotechnology Industry Organization (BIO) of 748 new drug applications (NDAs) and biologics license applications (BLAs) shows a nearly 20% increase in the rate of approvals for second-round submissions in response to a first-round complete response letter (CRL). The analysis, which tracked NDA and BLA submissions made between 2005 and 2010, shows a 55% approval rate for first-round submissions. The total approval rate jumped nearly 20% to 74.6% after ...
  • Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...