Center for Drug Evaluation and Research (CDER)

Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via the ListServ

1. Authorized Generic Drugs. The Food and Drug Administration announced in a Federal Register notice of July 28, 2009, the agency is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. The agency is taking this action as part of its implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.
http://edocket.access.gpo.gov/2009/pdf/E9-17963.pdf

2. New Guidance. The Food and Drug Administration announced in a Federal Register notice of July 30, 2009, the availability of a guidance for industry entitled ‘‘Drug-Induced Liver Injury: Premarketing Clinical Evaluation.’’ This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.
http://edocket.access.gpo.gov/2009/pdf/E9-18135.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

3. Rates for Prescription Drug User Fees for Fiscal Year (FY) 2010. The Food and Drug Administration announced in a Federal Register notice of August 3, 2009, the rates for prescription drug user fees for fiscal year (FY) 2010. The Federal Food,Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720). These fees are effective on October 1, 2009, and will remain in effect through September 30, 2010. For applications and supplements that are submitted on or after October 1, 2009, the new fee schedule must be used. Invoices for establishment and product fees for FY 2010 will be issued in August 2009, using the new fee schedule.
http://edocket.access.gpo.gov/2009/pdf/E9-18457.pdf

4. New Guidance. The Food and Drug Administration announced in a Federal Register notice of August 7, 2009, the availability of a guidance for industry entitled ‘‘Pharmaceutical Components at Risk for Melamine Contamination.’’ This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding to better control their use of at-risk components that might be contaminated with melamine. The guidance explains that the agency is recommending that at-risk components be properly tested for melamine contamination before they are used in the manufacture or preparation of drugs or drug products.
http://edocket.access.gpo.gov/2009/pdf/E9-18952.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175984.pdf

5. Warning Letters. The Food and Drug Administration announced in a Federal Register of August 11, 2009, a program to support public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of postinspection responses to inspectional observations that are communicated to a firm through issuance of a form FDA 483, list of inspectional observations. The program will begin on September 15, 2009.
http://edocket.access.gpo.gov/2009/pdf/E9-19107.pdf

6. Charging Patients for Investigational Drugs. The Food and Drug Administration announced in a Federal Register notice of August 13, 2009, that the agency is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted. This rule is effective October 13, 2009.
http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf

7. Expanded Access for Treatment Use. The Food and Drug Administration announced in a Federal Register notice of August 13, 2009, that the agency is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. This rule is effective October 13, 2009.
http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf

8. FDA’s Transparency Task Force The Food and Drug Administration announced in a Federal Register notice of August 18, 2009, that the agency is reopening until November 6, 2009, the comment period for the notice of public meeting and request for comments that appeared in the Federal Register of June 3, 2009 (74 FR 26712). In the notice of public meeting and request for comments, FDA’s Transparency Task Force requested comments on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public. The agency is taking this action because the agency is planning a second public meeting this fall and is reopening the comment period to allow interested persons additional time to submit comments.
http://edocket.access.gpo.gov/2009/pdf/E9-19778.pdf

9. Reorganization of the Office of the Commissioner. The Food and Drug Administration announced in a Federal Register notice of August 18, 2009, that the agency has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the realignment of four Deputy-level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).
http://edocket.access.gpo.gov/2009/pdf/E9-19680.pdf

10. MaPPs. A MaPP (Manual of Policies and Procedures) is a written statement issued by 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 the CDER.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM174552.pdf

11. The Small Business Advocate. The Small Business Advocate is a publication of the Small Business Administration.
http://www.sba.gov/advo/research/sbqei0902.pdf
Ron Wilson ronald.wilson@fda.hhs.gov 301-796-3177