martes, 30 de septiembre de 2014

CDER SBIA Update: Recent Federal Register Notices

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Recent Federal Register Notices
1. Submission of a Proposed Draft Guidance for Industry on Developing Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of a Public Docket
FDA is establishing a public docket to discuss issues related to developing drugs for Duchenne muscular dystrophy (DMD). During a public-private policy forum for DMD on December 12, 2013, FDA agreed that Parent Project Muscular Dystrophy (PPMD) and other interested parties in the DMD community could submit for FDA consideration a proposal for a draft guidance for industry on developing drugs for DMD. That proposed draft guidance was submitted to FDA on June 25, 2014. FDA values the guidance provided by the DMD community and is posting the document to seek additional guidance and public comment.
2. Report on the Standardization of Risk Evaluation and Mitigation Strategies  
FDA is announcing the availability of a draft report entitled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into the existing and evolving health care system. FDA is publishing this report to allow the public to provide comment on the report as it relates to PDUFA.
3. Public Meeting regarding the Development and Regulation of Abuse-Deterrent Formulations of Opioid Medications
On October 30 and 31, 2014, FDA will host a public meeting at the Sheraton, Silver Spring, MD to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA’s approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties.  This meeting is now open for registration.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
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