viernes, 14 de febrero de 2014

CDER SBIA Update: New Meetings, Notices, and Guidance Documents

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FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

New Meetings, Notices, and Guidance Documents

Meetings and Notices

1. Come to FDA’s GDUFA Regulatory Science Initiatives Public Meeting
FDA is hosting The Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2015 research priorities.

FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2015 Regulatory Science Plan.

The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 16, 2014, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.

Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing
If you wish to attend, either in person or via webcast, or present at the hearing, please email by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). Those without email access can register by contacting Thushi Amini ( by April 25, 2014. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.
2. Improving the Quality of Abbreviated New Drug Application Submissions to the FDA; Establishment of a Public Docket
FDA is establishing a public docket to receive input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements to FDA's Office of Generic Drugs (OGD). Specifically, FDA is interested in hearing about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help address, for example by providing more or better information to industry.
3. Public Workshop: Society of Clinical Research Associates-Food and Drug Administration: FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice  
FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SoCRA). The public workshop regarding FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA, and to facilitate interaction with FDA representatives.

4. Reopening of the Comment Period: Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on INDs - Determining Whether Human Research Studies Can Be Conducted Without an IND
The FDA is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled Investigational New Drug Applications (INDs)—Determining whether Human Research Studies can be Conducted without an IND. We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).

Guidance Documents

1. Electronic Submissions Guidance documents:

FDA has released a series of guidance documents intended to assist sponsors, applicants, and others making regulatory submissions to the FDA in electronic format:

2. Guidance for Industry and FDA Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information  
This guidance provides recommendations on when to use a Dear Health Care Provider (DHCP) letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible. This guidance finalizes the draft guidance issued in November 2010.

3. Draft Guidance for Industry on Analgesic Indications: Developing Drug and Biological Products
This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain. Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs.
Federal Register Notice
Guidance Document

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry 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 CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
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