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Researching Drug Studies across European Public Assessment Reports & FDA Approval Packages Linda Bowen, MS, RAC Director RI, US Region sanofi-aventis Insert.

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Presentation on theme: "Researching Drug Studies across European Public Assessment Reports & FDA Approval Packages Linda Bowen, MS, RAC Director RI, US Region sanofi-aventis Insert."— Presentation transcript:

1 Researching Drug Studies across European Public Assessment Reports & FDA Approval Packages Linda Bowen, MS, RAC Director RI, US Region sanofi-aventis Insert your logo in this area then delete this text box.

2 2 References - US CDER approved NDAs (SBoA) http://www.accessdata.fda.gov/scripts/cder/drug satfda/ http://www.accessdata.fda.gov/scripts/cder/drug satfda/ CDER FOI New Drug Approval Packages http://www.fda.gov/cder/foi/nda/index.htm http://www.fda.gov/cder/foi/nda/index.htm CBER approved devices http://www.fda.gov/cber/efoi/pma.htm http://www.fda.gov/cber/efoi/pma.htm CBER approved biologics http://www.fda.gov/cber/efoi/nda.htm http://www.fda.gov/cber/efoi/nda.htm CDRH approved PMAs http://www.fda.gov/cdrh/pmapage.html http://www.fda.gov/cdrh/pmapage.html

3 3 References - US Summaries of Medical & Clinical Pharmacology Reviews of Pediatric Studies http://www.fda.gov/cder/pediatric/Summaryreview.htm http://www.fda.gov/cder/pediatric/Summaryreview.htm Pediatric Exclusivity Determinations Made under Section 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by FDAAA http://www.fda.gov/cder/pediatric/bpca_determination.htm http://www.fda.gov/cder/pediatric/bpca_determination.htm

4 4 References - US Advisory Committee briefing packages, transcripts, minutes http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm Clinical Trial Disclosure http://www.clinicaltrials.gov/ http://www.clinicaltrials.gov/ Patent and Exclusivity Information (Drugs) http://www.fda.gov/cder/ob/ http://www.fda.gov/cder/ob/ Postmarketing Commitments Database http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

5 5 References - EU Summaries of Opinion http://www.emea.europa.eu/htms/human/opinion/opinion.htm http://www.emea.europa.eu/htms/human/opinion/opinion.htm EPARs for authorized medicinal products for human use http://www.emea.europa.eu/htms/human/epar/a.htm http://www.emea.europa.eu/htms/human/epar/a.htm European MRI-Product Index http://www.hma.eu/mri.html http://www.hma.eu/mri.html EudraPharm http://eudrapharm.eu/eudrapharm/searchbykeywordresult.do http://eudrapharm.eu/eudrapharm/searchbykeywordresult.do

6 6 References - EU Marketing Authorization Withdrawals and Suspensions - Medicinal Products for Human Use http://www.emea.europa.eu/htms/human/withdraw/withdraw.htm http://www.emea.europa.eu/htms/human/withdraw/withdraw.htm Public Assessment Report in case of Withdrawal of Application http://www.emea.europa.eu/htms/human/withdraw/withdrawapp/bac kground.htm http://www.emea.europa.eu/htms/human/withdraw/withdrawapp/bac kground.htm Refusal Assessment Report in case of negative CHMP opinion http://www.emea.europa.eu/htms/human/refusals/background.htm http://www.emea.europa.eu/htms/human/refusals/background.htm Latest Press Releases http://emea.europa.eu/ http://emea.europa.eu/

7 7 References - EU Summaries of Opinion Orphan Designation http://www.emea.europa.eu/htms/human/orphans/opinions.htm http://www.emea.europa.eu/htms/human/orphans/opinions.htm Decisions of the EMEA on pediatric investigation plans, deferrals or waivers http://www.emea.europa.eu/htms/human/paediatrics/decisions.htm http://www.emea.europa.eu/htms/human/paediatrics/decisions.htm Opinions on medicines for use outside the EU http://www.emea.europa.eu/htms/human/non_eu_epar/background. htm http://www.emea.europa.eu/htms/human/non_eu_epar/background. htm

8 8 References - Canada Summary Basis of Decision (Drugs) http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd- smd/phase1-decision/drug-med/index_e.html http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd- smd/phase1-decision/drug-med/index_e.html Drug Product Database http://www.hc- sc.gc.ca/dhp-mps/prodpharma/databasdon/index_e.htmlhttp://www.hc- sc.gc.ca/dhp-mps/prodpharma/databasdon/index_e.html Notice of Compliance http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/index_e.html http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/index_e.html NOC with Conditions http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/conditions/index_e.html http://www.hc-sc.gc.ca/dhp- mps/prodpharma/notices-avis/conditions/index_e.html Patent Register http://www.patentregister.ca/ http://www.patentregister.ca/

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