Outsourcing Clinical Supplies Manufacturing | Page 9

References » 1. BCC Research. Contract Pharmaceutical Manufacturing, Research and Packaging: Global Markets. Report Code PHM043D. September 2011. http://www.bccresearch.com/report/global-contract-pharmaceuticalmanufacturing-phm043d.html. Accessed February 12, 2013. 2. US Food and Drug Administration. Import Alert 66-66. http://www. accessdata.fda.gov/cms_ia/importalert_202.html. Accessed February 13, 2013. 3. US Department of Justice. Press release: California Man Sentenced for Importing Adulterated Cancer Drugs; Forfeits $1.4 Million & Land Rover Automobile. August 23, 2012. http://www.fda.gov/ICECI/ CriminalInvestigations/ucm316986.htm. Accessed February 13, 2013. 4. US Food and Drug Administration. Information on Heparin. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm112597. htm. Accessed February 13, 2013. 5. US Food and Drug Administration. Melamine Pet Food Recall of 2007. http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/ ucm129575.htm. Accessed February 13, 2013. 6. US Food and Drug Administration. Counterfeit Bulk Drugs. Statement of Jane E Henney, MD. October 3, 2000. http://www.fda.gov/NewsEvents/ Testimony/ ucm114871.htm. Accessed February 28, 2013. 7. US Government Printing Office. 21 CFR 201.125 – Drugs for Use in Teaching, Law Enforcement, Research, and Analysis. http://www.gpo. gov/fdsys/granule/CFR-2011-title21-vol4/CFR-2011-title21-vol4-sec201-125/ content-detail.html. Accessed February 13, 2013. 8. US Food and Drug Administration. Regulatory Procedures Manual. Chapter 9: Import Operations and Actions. August 2012. http://www.fda.gov/downloads/ICECI/ComplianceManuals/ RegulatoryProceduresManual/UCM074300.pdf. Accessed February 13, 2013. 9. US International Trade Commission. Harmonized Tariff Schedule of the United States (2013). http://hts.usitc.gov/. Accessed February 13, 2013. 10. US Customs and Border Protection. Importing into the United States: A Guide for Commercial Importers. CBP Publication No. 0000-0504. November 2006. http://www.cbp.gov/linkhandler/cgov/newsroom/ publications/trade/iius.ctt/iius.pdf. Accessed February 13, 2013. Author Bio » Nikolas Burlew, Vice President, GxP/CMC Quality Assurance, Clinipace Worldwide Nik Burlew is a Regulatory and Strategic Development QA professional working under GMP and GLP regulations providing auditing, training, system development, and project management services, in addition to authoring CMC sections for US and EU applications. clinipace.com 8