lunes, 24 de febrero de 2014

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

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Meetings, Notices and Public Dockets
1. FDA/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain

FDA Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.” The public conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives. The public conference will be held on March 19 and 20, 2014 on the campus of Xavier University in Cincinnati, OH.

2. Sunscreen products Time and Extent (TEA) Application Feedback Letters

FDA has issued 2 letters to manufacturers requesting additional information to support their applications requesting that certain sunscreen ingredients currently marketed in other countries be marketed in the United States via the Time and Extent Application (TEA) process. These letters are located on the FDA Sunscreen webpage.

3. Over-The-Counter Drug Monograph System-Past, Present, and Future; Public Hearing

FDA is announcing a public hearing to obtain input on the Over-The-Counter (OTC) Drug Review (sometimes referred to as the OTC Monograph Process, OTC Monograph, or OTC Drug Review). The Agency would like input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs (sometimes referred to as OTC drugs) marketed under the OTC Drug Review. This public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process.

The public hearing will be held on March 25th and 26th at FDA's White Oak Campus in Silver Spring, MD.

4. Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Establishment of a Public Docket

FDA is establishing a public docket to receive information and comments on standards for the interoperable exchange of information associated with transactions involving human prescription drugs in a finished dosage form (prescription drugs) to comply with new requirements in the Drug Supply Chain Security Act (DSCSA). We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers. In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs. This action is related to FDA's implementation of the DSCSA.

Guidance Documents

1. Draft Guidance for Industry on New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products

This draft guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products (fixed combinations). If the guidance is finalized, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of “new chemical entity,” regardless of whether that drug substance is approved alone or in certain fixed-combinations.

2. Guidance for Industry: International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility

The E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance.

3. Draft Guidance for Industry on Analytical Procedures and Methods Validation for Drugs and Biologics
This revised draft guidance supersedes the 2000 draft guidance for industry on “Analytical Procedures and Methods Validation” and, when finalized, will also replace the 1987 FDA guidance for industry on “Submitting Samples and Analytical Data for Methods Validation.” This draft guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. 

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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