Division Director Memo for Tamiflu
...However, the division recognizes both the practical limitations of recruiting sufficient.....Director, Division of Antiviral Drug Products.. cc: NDA 21-087.. HFD-530/WuT/Murray.. HFD.....Division Director Memorandum.. NDA: 21-087.. Drug and indication: Oseltamivir (TamifluTM) for..
http://www.fda.gov/cder/drug/infopage/tamiflu/directormemo.htm (score=100)

Microsoft Word - 7310.1R.doc
...A memorandum to the Board from the Division Director through the Office Director, recommending a.....The MO's Division Director will inform the employee of the final decision to convert, extend, or.....If the Board's input is requested, the MO's Division Director is responsible for..
http://www.fda.gov/cder/mapp/7310.1R.pdf (score=93)

Microsoft Word - 6020.8.doc
...office director, associate director for regulatory affairs, new drug chemistry director.....applications, unless an alternative time frame is agreed to by the division and office.....division director or office director has not written a separate review, he or she should..write a..
http://www.fda.gov/cder/mapp/6020.8.pdf (score=93)

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...Team Leader, Division Director or Deputy Director.. Ensures consistent recommendations are provided.....Once the review is finalized and has the concurrence of the Division Director, it is.. forwarded to.....through the team leader for corrections and endorsement, and to the Division Director.. for..
http://www.fda.gov/cder/mapp/5210-6.pdf (score=93)

Microsoft Word - 5240.7.doc
...appropriate, the division director or deputy division director should provide..concurrence before.....During the first review cycle, the division director or deputy division director should.. also.....Ensure consistent and appropriate use of the policy within the division for requesting..
http://www.fda.gov/cder/mapp/5240.7.pdf (score=87)

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.....DHCP letter is to correct misleading or violative promotional materials, the Division of..
http://www.fda.gov/cder/mapp/6020.10.pdf (score=80)

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...team leader completes the review, another team leader or the deputy division director should do the.....the reassignment, and obtains the Division Director's concurrence and signature on..the.....another in the Division of Bioequivalence (DBE) to prevent a delay in completing that..
http://www.fda.gov/cder/mapp/5210-2.pdf (score=80)

drafting, circulating and signing chemistry, manufac. and cont
...supplements requiring ODE Division Director sign-off are the responsibility of the ODE or ODE.....supplements requiring ODE Division Director sign-off will be coordinated by the ONDC co-located.....understood that the usual case should be that there is agreement between the ODE Division Director..
http://www.fda.gov/cder/mapp/5310-2.pdf (score=80)

IND Process and Review Proced. Including Clinical Holds
...Ensure that a clear record is created, signed, or initialed by the division director,which.....Directors, Chiefs, Project Management Staffs, Center Project Management Director,and.....Ensure that a letter, signed by the division director or acting division..director is sent to the sponsor detailing..
http://www.fda.gov/cder/mapp/6030-1.pdf (score=74)

Microsoft Word - 4520.2.doc
...If at the end of this 10-day period there is no reply from the division, the originator.....copy sent to the OND review Division Director. 5. DDMAC will have 10 business days in which to make.....make a second request with courtesy copies to OTCOM's Drug Information Division ..Director and the..
http://www.fda.gov/cder/mapp/4520.2.pdf (score=74)

Overtime Policy for ODE III
...The usual request will be countersigned by the Division Director or Deputy..Division.....staff in the division or an inordinately large amount or work which could not..be.....ODE III Management Officer (cc to Office Director and Division Director) by E-mail of the need for overtime/comp..
http://www.fda.gov/cder/mapp/6301-3.pdf (score=74)

Microsoft Word - 7400.4.doc
...proposed clinical studies remains the responsibility of the review division director;however, the review division director will.....genetic toxicology test may lead to a decision by the review division director to..impose a.....GTRC believes that the review division director's regulatory decision is inconsistent..with..
http://www.fda.gov/cder/mapp/7400.4.pdf (score=67)

Requests for Expedited Review of Supplements to Approved ANDAs
...and consult with the Division director who will concur or..not concur. The Division Director's.....recommendation and forward it to the Division Director. (4) The Division Director will decide.....Director, Office of Generic Drugs..11/1/95.. Page 1.. CENTER FOR DRUG EVALUATION AND..
http://www.fda.gov/cder/mapp/5240-1.pdf (score=61)

C:TL2STAGINGIM0648.PDF
...between the sponsor and the Division regarding the unique challenges of demonstrating.....NDA 21-036 Division Director Memorandum Page 2.. meeting have either been resolved, or have been.....NDA 21-036 Division Director Memorandum Page 7.. safety profile of this product is acceptable for..
http://www.fda.gov/cder/foi/appletter/1999/21036ddm.pdf (score=61)

Volunteer Prgm for Students
...The Division Director exercises final approval authority regarding participation in the..Volunteer.....be returned to the appropriate CDER Division at least two weeks before the..student's.....forwarded to the Division Director for endorsement. The Division Director exercises..final approval authority regarding..
http://www.fda.gov/cder/mapp/4550-1.pdf (score=54)

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...The Division Director, Deputy Division Director, or Staff Director will countersign the.....is a need caused by the inability to fully staff the division, or when there is an.....cover only one pay period and must be approved by the Deputy Director,Administration. In..
http://www.fda.gov/cder/mapp/7620-3.PDF (score=48)

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...If a consult is overdue by 30 days, the OGD Division Director or a designee in the division issuing.....If the consult is overdue by 60 days, the Director of OGD or designee is informed and.....It is distributed to the Director, Deputy.. Director, Division Directors, Approvals Manager and other project..
http://www.fda.gov/cder/mapp/5200-6.pdf (score=48)

The Food and Drug Administration's Development, Issuance, and Use of...
...All Level 2 guidance documents will receive the sign-off of an official at the Division Director.....Questions related to an appeal of guidance documents in ORA may be answered by the.....4\ If a matter is unresolved at the level of the Center Director, or if little progress is..
http://www.fda.gov/opacom/fedregister/frfeb2797.html (score=48)

Resolution of Disputes
...case of a reviewing medical officer, a division director or deputy director..reviews the primary.....If the division director and the office director disagree, the previously..described principles.....opinion to the reviewer, division director, and, if appropriate, office..director for informational..
http://www.fda.gov/cder/mapp/4151-1.pdf (score=48)

Microsoft Word - 5240.9.doc
...Consult the appropriate Chemistry Division Director or Deputy Division Director for.. any global supplements to determine.....The OGD Chemistry Division Director or Deputy Division Director will: 1. Determine whether multiple supplements qualify as..
http://www.fda.gov/cder/mapp/5240.9.pdf (score=48)

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