Luk Consulting
"CMC Right the First Time"
Drug Eluting Devices
Drug-Device Combination Product
Pharmaceutical Product Development
Drug Delivery Platform Development
Links
I have included a number of hyperlinks that you may find useful in your daily product development work
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Euromed MedTech Virtual Museum www.medtechmuseum.eu/Virtual Guide on Very Useful Introductions to the Medical Device Industry
Posted January 26, 2010 at 11:18 PM -
FDA Office of Combination Products (OCP) Website www.webs.comPosted January 16, 2010 at 8:27 PM -
FDA Dissolution Method Search www.accessdata.fda.gov/scripts/cder/dissolution/index.cfmPosted January 16, 2010 at 9:39 PM -
FDA Inactive Ingredient Search for Approved Drug Products www.accessdata.fda.gov/scripts/cder/iig/index.cfmPosted January 16, 2010 at 8:23 PM -
International Pharmaceutical Excipients Council of the Americas (IPEC) www.webs.comPosted January 16, 2010 at 8:16 PM -
FDA Drug Master Files (DMF) Information Page www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htmPosted January 16, 2010 at 8:21 PM -
Search for FDA guidance documents www.webs.comPosted January 16, 2010 at 8:25 PM -
Link to International Conference on Hamonization (ICH) Quality Guidelines www.ich.org/cache/compo/363-272-1.html#Q1A(R2)Posted January 16, 2010 at 8:31 PM -
US Pharmacopeia (USP) Home Page www.usp.org/USPNF/compendialTools.htmlPosted January 16, 2010 at 9:38 PM -
European Medicines Agency (EMEA) Regulatory Guidances www.ema.europa.eu/htms/human/raguidelines/intro.htmPosted January 16, 2010 at 9:42 PM -
European Medicines Agency (EMEA) Scientific Guidances www.ema.europa.eu/htms/human/humanguidelines/background.htmPosted January 16, 2010 at 10:19 PM -
European Directorate for the Quality of Medicines & Health Care (EDQM), including link to European Pharmacopeia www.edqm.eu/en/Homepage-628.htmlPosted January 16, 2010 at 9:53 PM -
Japanese Pharmacopeia (15th edition) jpdb.nihs.go.jp/jp15e/JP15.pdfPosted January 16, 2010 at 9:55 PM -
United States Patents and Trademark Office (USPTO) Patent Search patft.uspto.gov/Posted January 16, 2010 at 9:59 PM -
World Intellectual Property Organization Patent Search www.wipo.int/pctdb/en/Posted January 16, 2010 at 10:03 PM -
FDA guidances on using ISO 10993 for biocompatibility testing www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htmPosted January 28, 2010 at 11:24 PM -
510K -- FDA calls for a meeting re ``Strengthening the Center for Devices and Radiological Health's 510(k) Review Process" edocket.access.gpo.gov/2010/2010-1620.htmFebruary 18, 2010
Posted January 28, 2010 at 11:37 PM -
EMEA Guideline on Biosimilars www.ema.europa.eu/pdfs/human/biosimilar/043704en.pdfPosted January 28, 2010 at 11:13 PM -
European Medical Device Directives 93/42/EEC eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDFPosted January 30, 2010 at 5:54 PM
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