The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
1. Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease
This draft guidance outlines FDA’s current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer’s disease (AD) that occur before the onset of overt dementia. Specifically, this guidance addresses FDA’s current thinking regarding the selection of patients with early AD, or who are determined to be at risk of developing AD, for enrollment into clinical trials. The selection of outcome measures for trials in these populations that are designed to demonstrate a clinical benefit, as well as the manner in which disease modification might be demonstrated, are also addressed.
2. Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products
The purpose of this document is to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. The guidance outlines, and recommends adoption of, a risk-based approach to evaluating and mitigating the potential for immunogenicity that may affect the safety and efficacy of therapeutic protein products. The guidance describes various product- and patient-specific factors that can affect the immunogenicity of protein therapeutics and provides recommendations pertaining to each of these factors that may reduce the likelihood that these products will generate an immune response. In addition, the guidance offers a series of recommendations for risk mitigation in the clinical phase of development of protein therapeutics. The draft guidance also provides supplemental information on the diagnosis and management of particular adverse consequences of immune responses to protein therapeutics and contains brief discussions of the uses of animal studies and the conduct of comparative immunogenicity studies.
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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