The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring.'' This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance makes clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring The Food and Drug Administration (FDA) is announcing an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. Guidances that are no longer up to date, and for which more current information is available, will be withdrawn. Guidances that reflect CDER's current thinking, CDER will decide whether to revise or finalize. This notice describes CDER's initiative, announces the first group of guidances to be withdrawn, describes in general terms draft guidances under consideration for revision or finalization, and explains how CDER is making this process as transparent as possible. Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).'' Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop The Food and Drug Administration (FDA or the Agency) is announcing the start of the Secure Supply Chain Pilot Program (SSCPP). The SSCPP is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and active pharmaceutical ingredients (APIs) imported into the United States that meet the criteria for selection under the program. This notice outlines the eligibility requirements and the process for applying for participation in the SSCPP. Secure Supply Chain Pilot Program The Food and Drug Administration's (FDA) Office of Orphan Products Development is announcing the following meeting entitled ``The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop.'' This 1-day workshop is intended to provide valuable information about the FDA and European Medicines Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, and the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as academics.
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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