The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
1. Assessment Program for the Enhanced Review Transparency and Communication for NME NDAs and Original BLAs in PDUFA V – Request for Comments FDA is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). The Program is part of the FDA performance commitments under the proposed fifth authorization of the Prescription Drug User Fee Act (PDUFA), which, if enacted into law, will allow FDA to collect user fees for the review of human drug and biologics applications for fiscal years (FYs) 2013-2017. The Program is described in detail in section IIB of the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017.'' The Program will be evaluated by an independent contractor in an interim and final assessment. As part of the FDA performance commitment, FDA is providing a period of 30 days for public comment on the statement of work before letting the contract for the assessment. Details are included in the Federal Register Notice 2. Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids FDA today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions. The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overuse, and death. The REMS is part of a multi-agency Federal effort to address the growing problem of prescription drug abuse and misuse. The REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain. For more information, please visit: ER/LA opioid REMS
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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