lunes, 2 de diciembre de 2013

CDER Small Business Update: New Guidance Documents and Federal Register Notices

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

New Guidance Documents and Federal Register Notices

1. Re-opening of Comment Period: GDUFA Questions and Answers Draft Guidance (Revision 1)

FDA is reopening the comment period for the notice of availability entitled “Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1). FDA is reopening the comment period due to the inability of some commenters to submit comments through the www.regulations.gov Web site from November 4, 2013, through November 13, 2013, due to technical difficulties.
Please submit either electronic or written comments to the docket by December 11, 2013. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Federal Register Notice

2. Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public Hearing

FDA is rescheduling a December 4, 2013, public hearing to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency use eyewash products, announced in the Federal Register of Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public hearing to March 7, 2014, and updating the related procedural dates that appeared in the September 18, 2013, notice.

Federal Register notice.

3. Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

When finalized, this draft guidance will replace the guidance of the same title issued January 25, 2012. The draft guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human drugs, including biological drug products, and prescription animal drugs and articulates the circumstances under which FDA intends to exercise enforcement discretion.

Federal Register Notice

Draft Guidance

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.