Microsoft Word - 6020.10.doc
...CDER organizational units as needed, and advise the Division Director on the content of or.....Seek input from the supervisor, the Division Director, and other FDA personnel as needed.....Center Director..Deputy Center Director..OND Director..Deputy OND Director..Office of Pharmacoepidemiology and Statistical..
http://www.fda.gov/cder/mapp/6020.10.pdf (score=100)
Congressional Testimony
...Director, Deputy Director of the Center for Biologics Evaluation and Research before the Subcommittee on.....Director, Deputy Director of the Center for Biologics Evaluation and Research, to discuss FDA's response to.....Deputy Commissioner, Food and Drug Administration, before the Subcomittee on Health..
http://www.fda.gov/ola/2002.html (score=53)
Guide to the Delegations of Authority - Travel
...The Center Director, Deputy Center Directors, and Executive Officer hereby..delegate the authority.....delegated to the Center Director, Deputies, and Executive Officers by the Associate.....CDER's listing and forward to the Director, Office of Financial..Management, HFA-100..
http://www.fda.gov/cder/mapp/4641-2.pdf (score=37)
FDA, Regualtory Delegations of Authority
...1) The Director and Deputy Director, CDRH, and the Director, Deputy Directors, Division and Deputy Division.....d) The Director and Deputy Director, CDRH, and the Director and Deputy Directors, CBER, and the Directors and.....2) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR..
http://www.fda.gov/smg/1410_406.htm (score=21)
July 2000 News Along the Pike
...Center Director Janet Woodcock, in an outstanding manner. award recognizes those whose.....to the OPS director, deputy directors and, He willingly works many extra hours.. performing their.....center or office in FDA enabling its effi- to the director and deputy director of the.. duties and does..
http://www.fda.gov/cder/pike/july2000.pdf (score=21)
Guidance for Review Staff and Industry: Good Review Management Principles...
...The review division, in consultation with the office director, may decide to convene an.....When the review division director in CDER has signature authority for an application, the.....director of the responsible office should also write a summary to document the basis for..
http://www.fda.gov/cber/gdlns/reviewpdufa.pdf (score=21)
News Along the Pike, July 2000
...Over the last few years, he served as a special assistant to the director and deputy director of the Office of.....White, HHS deputy assistant secretary for human resources, recently learned about the.....and Helen Winkle, Acting Director of the Office of Pharmaceutical Science, presented the..
http://www.fda.gov/cder/pike/july2000.htm (score=21)
Office of Biostatistics: Organization and Responsibilities
...Division of Biometrics I (HFD-710) Director (vacant) Kooros Mahjoob, PhD, Deputy Director and.....Biologics Therapeutics Statistical Staff (HFD-711) Aloka Chakravarty, PhD, Director.....Edward Nevius, PhD, Director.. Stephen E. Wilson, DrPH, Deputy Director.. Supports Office..
http://www.fda.gov/cder/Offices/Biostatistics/organization.htm (score=21)
Visio-CDER Org Charts (All).vsd
...Deputy Director.. Deputy Director for Science.. Associate Director for Policy.. Deputy Center.....Deputy Director.. Div of Drug Information.. Rachel Behrman, MD, M.Ph.. Div of Drug Risk.....Deputy Director.. Biologic Therapeutics Statistical.. Quality.. Div of Pulmonary Drug..
http://www.fda.gov/cder/cderorg/cder.pdf (score=21)
CDER DOA
...Director and Deputy Director of the Office of Epidemiology and..Biostatistics, Office of Review Management.....5) The Director and Deputy Director, Division of Anti-Infective Drug Products,Office of Drug Evaluation IV.....The Director, Deputy Center Director for Review Management, and Deputy..Center Director for..
http://www.fda.gov/cder/mapp/4634-1.pdf (score=21)
D:INTERNETGENERALTEAMBIO.PDF
...Deputy Commissioner for Operations..Deputy Commissioner/Senior Advisor to the Commissioner.....The Director of ORA's Office of..Enforcement will serve as mediator and arbitrator in.....Director, Office of Enforcement..Director, Office of Regional Operations..Chair, Biologics..
http://www.fda.gov/cber/genadmin/teambio.pdf (score=21)
FDA, Regualtory Delegations of Authority
...Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety.....a) The Director and Deputy Director, CDRH, Director and Deputy Directors, Office of Device.....Deputy Directors of the Office of Blood Research and Review, Office of Vaccines Research..
http://www.fda.gov/smg/1410_407.htm (score=8)
SMG 1410.304 - ESTABLISHING STANDARDS AND APPROVING ACCREDITING BODIES UNDER...
...The Director, Deputy Director, and Director of Regulations and Policy, Center for Food Safety and Applied.....The Acting Principal Deputy Commissioner approved this delegation on April 2, 2001 (Via.....Deputy Commissioner, Subject: Comprehensive Update to 21 CFR Part 5, Delegations of..
http://www.fda.gov/smg/1410_304.htm (score=85)
SMG 1410.301 - FOOD STANDARDS, FOOD ADDITIVES, GENERALLY RECOGNIZED AS...
...2) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform.....1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform.....3) The Director and Deputy Director, CVM, are authorized to perform all the functions of the Commissioner..
http://www.fda.gov/smg/1410_301.htm (score=54)
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...cover only one pay period and must be approved by the Deputy Director,Administration. In.....The Deputy Director, Administration, will reply by e-mail conveying the approval or..disapproval.....The Division Director, Deputy Division Director, or Staff Director will countersign the..
http://www.fda.gov/cder/mapp/7620-3.PDF (score=38)
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...If a consult is overdue by 30 days, the OGD Division Director or a designee in the.....It is distributed to the Director, Deputy.. Director, Division Directors, Approvals Manager and.....If the consult is overdue by 60 days, the Director of OGD or designee is informed and..
http://www.fda.gov/cder/mapp/5200-6.pdf (score=37)
Policies and Procedures for Organizational Changes
...A memorandum to the FDA Deputy Commissioner for Operations from..the FDA Deputy.....Center Director. Organizational changes at the office level and above must be approved by.....Commissioner for Operations from the FDA Deputy Commissioner for..Management and Systems..
http://www.fda.gov/cder/mapp/4642-1.pdf (score=22)
Guidance for Industry Wireless Medical Telemetry Risks and Recommendations
...Acting Director..Deputy Director.. Office of Compliance..Office of Device Evaluation.. Center for Devices..
http://www.fda.gov/cdrh/comp/guidance/1173.html (score=21)
News Along the Pike, April-May 2000
...Lillie served as the deputy director of the new Office of Post-Marketing Drug Risk Assessment.....The director, deputy and associate directors, administration, procurement and project.....Director of Office of Testing and Research, provided very important administration support..
http://www.fda.gov/cder/pike/aprilmay2000.htm (score=21)
Guidance for Review Staff and Industry: Good Review Management Principles...
...The review division, in consultation with the office director, may decide to convene an.....When the review division director in CDER has signature authority for an application, the.....Review Division Director/Deputy Office Director (in special circumstances) By Day 45 (30) Hold..
http://www.fda.gov/cber/gdlns/reviewpdufa.htm (score=21)
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