martes, 19 de agosto de 2014

CDER SBIA Update: New Training, OPD Grants Funds, User Fees and Guidance Documents

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

New Training, OPD Grants Funds, User Fees and Guidance Documents
1. Florida Pharmaceutical Training  
The U.S Food and Drug Administration, Florida District in collaboration with the International Society of Pharmaceutical Engineers (ISPE), cordially invites you to attend training for the Pharmaceutical Industry on Thursday, September 4, 2014. 
The training will take place at the Marriott Miami Airport located at 1201 NW 42 Ave, Miami, FL 33126. Registration will begin at 7:30 AM prompt, followed by informational sessions from 8:00 AM – 5:00 PM. 
The training will focus on common violations found during inspections such as Process Validation, Equipment Qualification and Cleaning Validation among others topics.  
This event represents an excellent opportunity to meet and greet FDA officials, learn more about our agency’s policyand procedures. We are also excited to count with the participation of two members from ISPE. They will be sharing their knowledge and expertise with us from the industry standpoint.  
The training is FREE to register, please send an email to Ms. Cariny A. Nuñez by no later than August 31st via email at  
Marriott Miami Airport has reserved a room block at a special rate of $99p/n, this special will be available until Friday, August 22nd. To make a reservation or to schedule shuttle services from the airport, please call the hotel at (305) 649-5000.
Don’t miss out this great opportunity of interacting with FDA officials and ISPE members. I look forward to seeing you at the Florida Pharmaceutical Training.

2. Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)  
FDA is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development grant program. The goal of FDA's Orphan Products Development (OPD) grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Federal Register Notice
3. User Fee Rates
In addition to the FY 2015 GDUFA user fee rates, FDA also announced the rates for biosimilar user fees,prescription drug user fees, and the establishment and re-inspection fees related to human drug compounding outsourcing facilities that elect to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
4. Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act  
This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
Federal Register Notice
Guidance Document
5. Revised Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format
This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the Clinical Pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This revised draft guidance replaces the 2009 draft guidance for industry entitled “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.”
Federal Register Notice
Guidance Document
6. Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products  
Therapeutic protein products may elicit immune responses, which may lead to serious or life-threatening adverse events for the patient or loss of efficacy of the product. This guidance is intended to assist manufacturers and clinical investigators in developing a risk-based approach in both the nonclinical and clinical phases of product development that will allow them to evaluate and reduce the likelihood that the immunogenicity of the product will cause harm to patients. This guidance finalizes the draft guidance issued in February 2013.

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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