Issuance of Directives in CDER
...Office Director who will check the directive MAPP for accuracy, endorse it,and return it.....The controversy will be presented to the CDER Deputy Director or..Associate Director that has.....Coordinate with the Associate Director for Policy to obtain concurrence of..affected units..
http://www.fda.gov/cder/mapp/4000-1.pdf (score=100)

Microsoft Word - 4000-2R.doc
...with his or her supervisor and then with the office or division director as appropriate.....to whether a guidance is a Level 1 or Level 2, contact the Associate Director for Policy.....Associate Director for Policy. For particularly significant Level 1 documents with Center..
http://www.fda.gov/cder/mapp/4000-2r.pdf (score=90)

CDER Key Officials
...Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products (DAAODP.....Associate Director for International Program ..Justina A. Molzon, J.D. HFD-001 301-594.....Associate Director of Pharmacology and Toxicology ..David Jacobson-Kram, Ph.D., D.A.B.T..
http://www.fda.gov/cder/directories/keyoffic.pdf (score=81)

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...ONDC Associate Director for Microbiology Division or other supervisory staff, as.....Director, CDER, to the Office Directors, Division Directors, supervisory chemists and.....working group will inform their team leader and their chemistry division director, the.. Originator: OPS Associate..
http://www.fda.gov/cder/mapp/7210-1.pdf (score=58)

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...from the CDER Associate Director for Policy, please E-mail the CDER Associate..Director.....Ensure that the goal date has concurrence from the CDER Associate Director for Policy.. for any.....CDER Associate Director for Policy will: 1. Concur or not concur with all goal dates for all issues..
http://www.fda.gov/cder/mapp/4140.5.PDF (score=55)

Microsoft Word - 4170.3.doc
...Draft the search request and forward it to the Director, DIDP, through the Litigation Team.....Consult with the Director, DIDP, and OCC on the information to be included in the document.....Consult with the Director, DIDP, and OCC as appropriate. Originator: Associate Director..
http://www.fda.gov/cder/mapp/4170.3.pdf (score=52)

FDA Office of International Programs
...Associate Director for Asia and the Pacific.. Julia Ho.. Associate Director for Africa, Europe and.....Associate Director for International Policy.. Lois Beaver.. Associate Director for International.....Associate Director for International Policy.. Barbara Ward-Groves.. Associate Director for..
http://www.fda.gov/oia/contact.htm (score=52)

CENTER FOR BIOLOGICS REORGANIZED
...Three Associate Directors have been established to manage the following program areas in.....Office of Establishment Licensing and Product Surveillance, Director, Jerome A. Donlon, M.....Office of Management, Director, Russell Abbott -- Office of Blood Research and Review..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00438.html (score=46)

Management of CAC, revision
...Associate Director for Pharmacology/Toxicology, Office of Review Management..October 28, 1996 10/30.....Associate Director for Pharmacology/Toxicology, Office of Review Management..October 28, 1996 10/30.....Associate Director for Pharmacology/Toxicology, Office of Review Management..October 28, 1996 10/30..
http://www.fda.gov/cder/mapp/7412-1.pdf (score=43)

Alternate Work Schedules for RPS
...The Associate Director for Policy will: 1. Review the RPS plan when appropriate and decide whether.....RPS core hours for approval by the Director of RPS. Employees..may not participate in.....exceptions to RPS core hours to the Associate Director for ..Policy. Employees will: 1..
http://www.fda.gov/cder/mapp/4140-2.pdf (score=43)

CBER Organizational Chart
...Associate Director for Medical and International Affairs: HFM-215 301-827-3977.. HFM-165 301-827.....Associate Director for Quality Assurance: Sherly L. Lard-Whiteford, Ph.D. HFM-4 301-827.....Associate Director for Policy: fax 301-827-3053.. Diane Maloney, J.D. HFM-10 301-827-0373 (fax 301..
http://www.fda.gov/cber/inside/orgover.pdf (score=40)

Microsoft Word - 5210-5.doc
...As with the initial hold,the Office Director will be notified and a letter signed by the.....Associate Director for Medical Affairs..Director, Division of Labeling and Program Support.....The Associate Director for Medical Affairs or the Director of the Division of..
http://www.fda.gov/cder/mapp/5210-5.pdf (score=37)

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...Evaluate the request, in consultation with the Director, DRP II and the Associate Director.....In conjunction with the Director, DRP II and the assigned ORP staff person,determine the.....background information to the ORP Project Manager with a copy to the Director, DRP II (HFD..
http://www.fda.gov/cder/mapp/4000-3pub.PDF (score=34)

MANUAL OF POLICIES AND PROCEDURES
...01his Web site is maintained by the Associate Direc.or for Policy an is updated.....166 dLIto the Associate Direc.or for Policy for tracking purposes.C /00110 0 9.23.7850 0.....Associate Director for Policy .. Page 2 4/29/98.. 7/01/03 9/13/2005 .. MANUAL OF POLICIES AND..
http://www.fda.gov/cder/mapp/4000-2_10_05.pdf (score=34)

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...for New Indications and Dosage Forms, from the Acting Associate Director for New..Drug Evaluation.....Associate Director, Pharmacology and Toxicology..05/09/01.. Page 1.. CENTER FOR DRUG EVALUATION AND.....Associate Director, Pharmacology and Toxicology..03/11/02.. Page 2.. CENTER FOR DRUG EVALUATION AND..
http://www.fda.gov/cder/mapp/6030-4.pdf (score=34)

SMG 1410.29 HEARINGS
...The Director and Deputy Director, CDRH, are authorized to hold hearings, and to designate other officials to.....Associate Director for Regulatory Policy and the Associate Director for Medical Policy.....Associate Director for Regulatory Policy and the Associate Director for Medical Policy..
http://www.fda.gov/smg/1410_29.html (score=31)

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...Associate Director for Electronic Review.. Date: 5/31/2000.. MANUAL OF POLICIES AND.....Associate Director for Electronic Review.. Date: 5/31/2000.. MANUAL OF POLICIES AND.....Associate Director for Electronic Review.. Date: 5/31/2000.. MANUAL OF POLICIES AND..
http://www.fda.gov/cder/mapp/7600-7.pdf (score=31)

clearance of speeches, articles, and other communication Mater
...Office Directors, Deputy Directors and Associate Directors are their own clearing.....Associate Director for Policy..11/07/95 01/26/99 Page 1.. CENTER FOR DRUG EVALUATION AND.....Associate Director for Policy..11/07/95 01/26/99.. Page 2.. CENTER FOR DRUG EVALUATION AND..
http://www.fda.gov/cder/mapp/4510-2.pdf (score=31)

Requests for expedited Review of NDA Chemistry supplements
...concurrence by the DNDC Director, the Chemistry Team..Leader will advise the company by.....Associate Director, Office of Pharmaceutical Science..6/11/99.. Page 1.. CENTER FOR DRUG.....Associate Director, Office of Pharmaceutical Science..6/11/99.. Page 2.. CENTER FOR DRUG..
http://www.fda.gov/cder/mapp/5310-3.pdf (score=31)

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...MPH, Associate Director, DOTCDP.. 12:00 Lunch.. 1:00 Charge to Committee.. Linda Katz, M.D.....Deputy director, DMEDP.. 8 :15 Bristol-Myers Squibb Presentation.. 9:45 Break.. 10:15 FDA.....MPH, Associate Director, DOTCDP.. 1:15 Discussion and Questions.. Break.. 4:30 Adjourn..
http://www.fda.gov/ohrms/dockets/ac/00/agenda/3622a2.pdf (score=28)

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