FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
 HHS Logo links to Department of Health and Human Services website
Skip navigationFDA Home Page | Dockets Home Page | Dockets Contacts and Location | Operating Status | Federal Register
horizonal rule

 

2007D-0168: Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NAD1 05/30/2007 FDA FDA 05/31/2007 30386-30388 09/28/2007 pdf
Signature: SHUREN, JEFFREY
EC1 08/16/2007 08/11/2007 Device Industry Surgical migraine clinic
Signature: Sultaneh, Ali
LET1 08/02/2007 08/02/2007 Private Industry Natco Pharma Limited pdf
Signature: Dr. AKS Bhujanga Rao
EC4 08/30/2007 08/29/2007 Drug Industry Johnson and Johnson PRD htm
Signature: Soons, Paul
EC3 08/30/2007 08/29/2007 Drug Industry ViroPharma Incorporated htm
Signature: Doyle, Thomas
EC2 08/30/2007 08/29/2007 Drug Industry Johnson No Attachment
Signature: Soons, Paul
C1 09/26/2007 09/26/2007 Private Industry ASTS pdf
Signature: Goran B. Klintmalm
C2 09/28/2007 09/28/2007 Drug Industry Endo Pharmaceuticals pdf
Signature: Mary Alice Raudenbush
C3 10/01/2007 10/01/2007 Drug Industry Wyeth Pharmaceuticals pdf
Signature: Roy J. Baranello
C4 10/01/2007 10/01/2007 Drug Industry Astellas Pharma US, Inc. ("Astellas") pdf
Signature: William E. Fitzsimmons
EC5 10/02/2007 09/28/2007 Drug Industry Axcan Scandipharm Inc. htm
Signature: Rousseau, Guy
NAD2 10/24/2007 FDA FDA 10/25/2007 60683-60684 12/24/2007 pdf
Signature: Jeffrey Shuren

Top |

Page last updated: January 28, 2008


Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management