The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
1. Guidance for Industry on Labeling for Human Prescription Drug and Biological Products; Implementing the Physician Labeling Rule Content and Format Requirements
This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under 21 CFR 201.56(d) and 201.57. FDA is issuing this guidance to provide recommendations for applicants developing labeling for new prescription drugs and revising labeling for already approved prescription drugs. This guidance also provides recommendations on developing Highlights of Prescribing Information (Highlights), formatting labeling, and procedural information.
2. Documents To Support Submission of an Electronic Common Technical Document
FDA is announcing the availability of the following revised final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: “The eCTD Backbone Files Specification for Module 1, version 2.1” (which includes the U.S. regional document type definition, version 3.1), and “Comprehensive Table of Contents Headings and Hierarchy, version 2.1.” Technical files that support these documents are also available on the Agency Web site.
The eCTD Backbone Files Specification for Module 1, version 2.1
Comprehensive Table of Contents Headings and Hierarchy, version 2.1
3. Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data
The purpose of this attachment is to assist sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. HCV resistance data submitted in appropriately formatted datasets is a critical component in the review of investigational antiviral products for the treatment of HCV. The information in this attachment will facilitate the development and regulatory review of anti-HCV products.
4. Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators
This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators.
5. Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application: Comment Request
FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug application (IND).
6. Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
FDA is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.
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.
- Email: CDERSmallBusiness@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/smallbusinessdrugs
- Widget: http://www.fda.gov/Drugs/ucm153379.htm
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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