The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
1. Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling
This draft guidance is intended to assist applicants and FDA review staff in making decisions about the placement and content of pediatric information in human prescription drug and biological products labeling in accordance with the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), as well as FDA prescription drug and biological product labeling regulations.
2. Draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex
FDA issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL). The FDA is encouraging manufacturers of FDA-regulated medical products to stop using statements on labels such as “latex free” or “does not contain natural rubber latex” because these statements are not scientifically accurate. Instead, the FDA recommends manufacturers use the labeling statement – “not made with natural rubber latex” – to indicate when NRL was not used as a material in the medical product or product container.
3. Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments
FDA is announcing the availability of a draft 5-year plan describing the Agency's approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Please submit either electronic or written comments by May 7, 2013.
4. National Compounding 2013 Inspections - Public Posting of 483s
FDA has posted 483s regarding inspections of compounding pharmacies.
5. Changes in the Office of Prescription Drug Promotion (OPDP)
The Office of Prescription Drug Promotion (OPDP) in the Office of Medical Policy works to protect the public health by ensuring that all prescription drug promotional labeling and advertising directed to health care professionals and consumers is truthful, balanced, and not misleading.
Recently, OPDP reviewed and analyzed the workload and review processes in its two divisions, the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion, in an effort to improve upon their overall impact and effectiveness. The goal of this analysis was to increase efficiency, improve work distribution, and eliminate redundancy. Through the analysis, OPDP concluded that a structure that integrates the review of health care professional-directed and consumer-directed promotion across the two divisions would meet this goal.
Toward this goal, OPDP will be restructuring its divisions and, pending final approval, will rename them the Division of Advertising and Promotion Review I and the Division of Advertising and Promotion Review II. Both divisions will handle health care and consumer promotion. As a way to distribute the work evenly, each division will oversee different therapeutic classes of drugs. These changes will allow OPDP to review direct-to-consumer (DTC) and health professional advertising more effectively.
We know that DTC advertising is often the catalyst for patients initiating conversations with their physicians about their untreated or undertreated conditions. It is also a subject of interest and debate among our stakeholders. The decision to restructure the divisions reflects our commitment to continue providing close oversight of DTC advertising. The new structure will improve efficiency in our program area and our ability to meet the health needs of the American public.
Our OPDP reviewers will continue to use a comprehensive surveillance, enforcement, and education program to foster superior communication of labeling and promotional information to both health care professionals and consumers.
Please find an updated list of reviewers and their new assignments at: OPDP Organization Listing
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.
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