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. New Guidance. The Food and Drug Administration announced in a Federal Notice of December 23, 2009, the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between thelocal regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region.

http://edocket.access.gpo.gov/2009/pdf/E9-30441.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073427.pdf

2. Amendment of the Informed Consent Regulations. The Food and Drug Administration (FDA) issued a proposed rule in the Federal Register of December 29, 2009, that, if finalized,would amend the informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic, and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that FDA update its informed consent regulations to require that the informed consent documents and processes for certain clinical investigations include a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank. http://edocket.access.gpo.gov/2009/pdf/E9-30751.pdf

3. New Guidance. The Food and Drug Administration (FDA) announced in the Federal Register of December 17, 2009, the availability of a draft guidance entitled ‘‘Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1).’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. http://edocket.access.gpo.gov/2009/pdf/E9-29991.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf

4. FDA Clinical Trial Requirements, Regulations, Compliance and GCP. The Food and Drug Administration (FDA) Florida District, in cosponsorship with The Society of Clinical Research Associates, Inc. (SoCRA), is announced in a Federal Register notice of December 17, 2009, a workshop entitled ‘‘FDA Clinical Trial Requirements, Regulations, Compliance and GCP.’’ This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry. The public workshop will be held on Wednesday, March 3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8 a.m. to 4:35 p.m. The public workshop will be held at The Wyndham Orlando Resort, 8001 International Dr., Orlando,FL 32819. http://edocket.access.gpo.gov/2009/pdf/E9-30017.pdf

5. Newly Added Guidance Documents. This website provides newly added guidance documents issued within the last three months. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

6. Orphan Drug Workshops. The FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases. Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs. The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195343.htm

7. FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, 5701 Marinelli Road, Bethesda, MD. Meeting Information and registration/

8. DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Meeting information and registration

Ron Wilson Director of Small Business Assistance    [email protected] 301-796-3177