viernes, 1 de mayo de 2015

CDER SBIA Update:New Meetings, Announcements, & Guidance Documents

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

 New Meetings, Announcements, & Guidance Documents

1. FDA’s Public Meeting on the Reauthorization of GDUFA
On June 15, 2015, FDA will hold a public meeting to seek input on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years.
FDA has published a notice in the Federal Register requesting input on the reauthorization. FDA will considerwritten comments received to the public docket up to 30 days after the public meeting and will publish the comments on FDA’s Web site.
FDA invites the public to comment on the GDUFA program and provide suggestions regarding the features FDA should propose for the next GDUFA program, especially:
- assessment of the overall performance of the GDUFA program to date, and
- aspects of GDUFA that should be retained, changed, or discontinued to further strengthen and improve the program.
The comment period to the public docket is currently open and will remain open until July 15, 2015.
Date:               June 15, 2015
Time:              9:00 a.m. to 5:00 p.m.
Location:        FDA White Oak Campus
                        10903 New Hampshire Avenue
                        Bldg. 31, Room 1503 (Great Room)
                        Silver Spring, MD 20993
To Register: If you wish to attend or present at the meeting, please email your information by June 1, 2015.

2. Communication Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket
FDA is announcing the establishment of a docket to obtain comments on the interim assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). FDA is also announcing a public meeting where the interim assessment will be discussed and public stakeholders may present their views on the Program to date.

3. Proposed rule to address data gaps for certain active ingredients in health care antiseptics
FDA has issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.The proposed rule does not require any health care antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing health care antiseptic products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects and development of bacterial resistance. Once the proposed rule is finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available.
Additional information: Health care antiseptics

4. Guidance for Industry; Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

5. Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product

6. Guidance for Industry; Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

7. Guidance for Industry; Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics

8. Draft Guidance for Industry; Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs

9. Draft Guidance for Industry; Environmental Assessment: Questions and Answers Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity

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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