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 transcript:

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 References - US CDER approved NDAs (SBoA) satfda/ satfda/ CDER FOI New Drug Approval Packages CBER approved devices CBER approved biologics CDRH approved PMAs

3 References - US Summaries of Medical & Clinical Pharmacology Reviews of Pediatric Studies Pediatric Exclusivity Determinations Made under Section 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by FDAAA

4 References - US Advisory Committee briefing packages, transcripts, minutes Clinical Trial Disclosure Patent and Exclusivity Information (Drugs) Postmarketing Commitments Database

5 References - EU Summaries of Opinion EPARs for authorized medicinal products for human use European MRI-Product Index EudraPharm

6 References - EU Marketing Authorization Withdrawals and Suspensions - Medicinal Products for Human Use Public Assessment Report in case of Withdrawal of Application kground.htm kground.htm Refusal Assessment Report in case of negative CHMP opinion Latest Press Releases

7 References - EU Summaries of Opinion Orphan Designation Decisions of the EMEA on pediatric investigation plans, deferrals or waivers Opinions on medicines for use outside the EU htm htm

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