CDER's Small Business Assistance Bulletin

1. New Guidance. The Food and Drug Administration announced in a Federal Register notice of January 13, 2010, the availability of a draft guidance entitled,‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval.’’ The draft guidance announced in this notice is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review. http://edocket.access.gpo.gov/2010/pdf/2010-426.pdf and http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf


2. New Guidance. The Food and Drug Administration (FDA) announced in a Federal Register notice of January 6, 2010, the availability of a guidance for industry entitled ‘‘New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products,’’ dated December 2009. As part of the Medical Device User Fee Amendments of 2007 (MDUFA) Commitment for the Performance Goals and Procedures commitment letter, FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to assist developers of medical imaging devices and imaging drug/biological products that provide image contrast enhancement. The final guidance announced in this document fulfills FDA’s commitment to issue guidance called for by the commitment letter. The guidance supercedes the draft guidance of the same title dated September 30, 2008. http://edocket.access.gpo.gov/2010/pdf/E9-31307.pdf and http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM195951.pdf


3. New Guidance. The Food and Drug Administration announced in a Federal Register notice of December 29, 2009, the availability of a guidance for industry entitled ‘‘Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions.’’ This guidance describes the circumstances in which FDA will not object to certain compounding of Tamiflu Oral Suspension in advance of receiving prescriptions. http://edocket.access.gpo.gov/2009/pdf/E9-30750.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM197162.pdf


4. New Guidance. The Food and Drug Administration announced in a Federal Register notice of January 8, 2010, the availability of a draft guidance for industry entitled ‘‘Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.’’ The draft guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop contingency production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the draft guidance is to provide to industry considerations for developing such emergency plans, as well as to discuss the Center for Drug Evaluation and Research’s (CDER’s) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies. http://edocket.access.gpo.gov/2010/pdf/2010-87.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM196497.pdf


5. Updated National Drug Code Directory. Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs. FDA inputs the full NDC number and the information submitted as part of the listing process into a database known as the Drug Registration and Listing System (DRLS), which is transforming into the electronic system (eDRLS). On a monthly basis, FDA extracts some of the information from the DRLS data base (currently, properly listed marketed prescription drug products and insulin) and publishes that information in the NDC Directory. A link is provided to the recently updated National Drug Code Directory. http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm


6. New MaPP. A MaPP (Manual of Policies and Procedures) is a written statement issued by the Center for Drug Evaluation and Research (CDER) management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A recent MaPP was issued by CDER.
This MaPP outlines policies and procedures in the Office of Biotechnology Products (OBP) in the Office of Pharmaceutical Science (OPS) and the Division of Manufacturing Product Quality (DMPQ) in the Office of Compliance (OC) designed to:
Ensure product quality as it relates to safety and efficacy of the product
Provide a team approach to product quality evaluation of biologics licensing applications
Define clear roles and responsibilities
Establish work processes that are effective
Develop a system that ensures problems are resolved in a timely and professional manner
The MaPP is available via this link: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM195932.pdf


7. 4th Annual FDA/DIA Statistics Forum. This conference is an opportunity for statisticians, clinicians and other interested professionals from industry, academia, CROs, and government agencies to learn about and assess current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products. The date of the Forum is April 18 - April 21, 2010 at the Marriott Bethesda North Hotel 5701 Marinelli Road North Bethesda, MD 20852. http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21503&eventType=Meeting
Ron Wilson Director of Small Business Assistance ronald.wilson@fda.hhs.gov 301-796-3177