Novartis Exelon NDA 20–823

Exelon (Rivastigmine Tartrate) Capsules; Company: Novartis Pharmaceuticals Corporation; Application No.: 20-823; Approval Date: 4/21/2000. Accessed on 2007-06-01 at: http://www.fda.gov/cder/foi/nda/2000/20823_Exelon.htm

Forms FDA 483 and FDA Regulatory Actions

NDA 20-823 Novartis Exelon: Form FDA 483 Issued to Kevin L. Keim Ph.D., Quintiles Pacific, Inc. 1999-01-13. Available from http://www.bioethicswatch.org/foia/quintiles483_19990113.pdf

NDA 20-823 Novartis Exelon: El-Hage A. Correspondence to Kevin L. Keim Ph.D., Quintiles Pacific, Inc. 1999-08-16. Available from http://www.circare.org/exelon/fda_quintiles_19990816.pdf (1)

NDA 20-823 Novartis Exelon: Form FDA 483 Issued to Richard L. Borison M.D. 1997-04-22. Available from http://www.bioethicswatch.org/foia/borison483_19970422.pdf

Borison, Richard L., M.D. FDA Docket No. 00N-1530: Proposal to Debar Notice of Opportunity for Hearing. 2002-11-22. Accessed on 2007-06-01 at: http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/121902/00n-1530.pdf

Department of Health and Human Services, Food and Drug Administration. Richard L. Borison M.D. Debarment Order. 68 FR 189 56299. 2003-09-30. Accessed on 2007-06-01 at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-24656.pdf

Form FDA 483 Issued to Richard L. Borison M.D. 1993-06-24. Available from http://www.bioethicswatch.org/foia/borison483_19930624.pdf

Diamond, Bruce I., Ph.D. FDA Docket No. 00N-1531: Proposal to Debar Notice of Opportunity for Hearing. 2002-11-26. Accessed on 2007-06-01 at: http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/121902/00n-1531.pdf

FDA Correspondence to Clinical Investigators (2)

Lepay DA. Correspondence to Marcel Chatel RE: NDA 20-823 Novartis Exelon inspection. 1998-05-27. Available from http://www.circare.org/exelon/fda_chatel_19980527.pdf

Barton BL. Correspondence to Peter Dal-Bianco RE: NDA 20-823 Novartis Exelon inspection. 1998-03-17. Available from http://www.circare.org/exelon/fda_dal-bianco_19980317.pdf

Barton BL. Correspondence to Peter M. Ripley, M.D. RE: NDA 20-823 Novartis Exelon inspection. 1998-02-24. Available from http://www.circare.org/exelon/fda_ripley_19980224.pdf

Barton BL. Correspondence to Patricia L. Walicke, M.D., Ph.D. RE: NDA 20-823 Novartis Exelon inspection. 1998-04-06. Available from http://www.circare.org/exelon/fda_walicke_19980406.pdf

FDA Inspection NDA 20-823 Novartis Exelon (3)

Lewin C. Clinical Inspection Summary NDA 20-823 Novartis Exelon. 2000-04-04. Available from http://www.circare.org/exelon/fdainspectionsummary_nda20-823_20000404.pdf

Young R. NDA 20-823 Novartis Exelon Clinical Investigator Inspections. 1998-02-26. Available from http://www.circare.org/exelon/fdamemo_nda20-823_19980226.pdf

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Media Coverage and Related

Borison gets prison after guilty pleas. Sandy Hodson and Tom Corwin. The Augusta Chronicle. 1998-10-10.
URL: http://tinyurl.com/fo75n

MCG researchers indicted on 172 counts. Paul Garber. The Augusta Chronicle. 1997-02-12.
URL: http://web.archive.org/web/19970412062832/http://augustachronicle.com/stories/021997/met_borison.html

College a victim, chief says. Paul Garber. The Augusta Chronicle. 1996-02-19
URL: http://web.archive.org/web/19970412062847/http://augustachronicle.com/stories/021997/met_borison2.html

MCG studies to get checkup. Paul Garber. The Augusta Chronicle. 1996-02-19
URL: http://web.archive.org/web/19970412062923/augustachronicle.com/stories/021997/met_mcg_reax.html

FDA is reviewing researchers' work. Paul Garber. The Augusta Chronicle. 1996-10-18.
URL: http://web.archive.org/web/19970413235603/augustachronicle.com/headlines/101896/fda_review.html

MCG looking at changes admid reseach investigation. Paul Garber. The Augusta Chronicle. 1996-10-06.
URL: http://web.archive.org/web/19990503023151/www.augustachronicle.com/headlines/100696/research.html

Investigators asking if medical reseachers diverted funds. Paul Garber and Wayne Partridge. The Augusta Chronicle. 1996-08-17.
URL: http://web.archive.org/web/20000517184931/www.augustachronicle.com/headlines/081896/investigation.html

Ex-Profs Charged in Psych Department Research Scam. Michael Jonathan Grinfeld. Psychiatric Times. 1997;14(4).
URL: http://www.psychiatrictimes.com/p970401b.html

Former VA psychiatrist sentenced to 15 years in jail. Office of Inspector General Department of Veterans Affairs (VAOIG) Press Release. 1998-10-09. Accessed on 2007-06-01 at: http://www.va.gov/oig/51/press99/borison-pr.htm

Researcher pleads guilty in massive fraud. Office of Inspector General Department of Veterans Affairs (VAOIG) Press Release. 1997-12-16. Accessed on 2007-06-01 at: http://www.va.gov/oig/51/press98/diamondpr.htm

Attorney General Announces Guily Plea in Medical College of Georgia Fraud Case. State of Georgia Attorney General Press Release. 1998-10-09. Accessed on 2007-06-01 at: http://www.state.ga.us/ago/press/press.cgi?prfile=PR.19981009.01

Attorney General Announces Guily Plea in Medical College of Georgia Fraud Case. State of Georgia Attorney General Press Release. 1997-12-16. Accessed on 2007-06-01 at: http://www.state.ga.us/ago/press/press.cgi?prfile=PR.19971216.01

Notes

1. NDA 20-823 Novartis Exelon, Administrative Documents and Correspondence. Accessed on 2007-06-01 at: http://www.fda.gov/cder/foi/nda/2000/20823_Exelon_admincorres.pdf

2. NDA 20-823 Novartis Exelon, Administrative Documents and Correspondence. Accessed on 2007-06-01 at: http://www.fda.gov/cder/foi/nda/2000/20823_Exelon_admincorres.pdf

3. NDA 20-823 Novartis Exelon, Administrative Documents and Correspondence. Accessed on 2007-06-01 at: http://www.fda.gov/cder/foi/nda/2000/20823_Exelon_admincorres.pdf

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