Pediatric Rule
...younger pediatric populations cannot take the adult formulation, may also deny pediatric.....produce a pediatric formulation had failed. The proposed rule would require the applicant.....produce a pediatric formulation had failed. FDA solicits comment on whether it is..
http://www.fda.gov/cder/guidance/pedrule.pdf (score=100)

Document
...Even minor variations in formulation, effectiveness. formula is stated as: such as the.....formulation to one axilla and the application .. range of 30 to 40 percent. Seven studies.....21), sweating was induced by having the formulation and supposedly devoid of .. report (43..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=98)

C:\Kavanagh Data\Reviews\DNPDP\NDA Suppl\20-699 S_030 & 20-151 S_02\ 4...
...The efficacy studies for GAD were conducted with the ER formulation, whereas the initial.....pre-NDA package OCPB requested a pediatric pharmacokinetic study with the ER formulation.....absorption of venlafaxine from an extended release formulation would be truncated before..
http://www.fda.gov/cder/foi/esum/2003/20699s030,20151s024.pdf (score=98)

Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further...
...Under this approval, you are authorized to manufacture a preservative-free bulk.....Manufacture of the preservative-free bulk formulation at a scale that is different from.....formulation of Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further..
http://www.fda.gov/cber/approvltr/dttachi050305L.htm (score=97)

þÿ
...receive the test formulation under the left axilla and the .. placebo control formulation.....the test formulation to one axilla and the application of a .. placebo control formulation.....minor variations in formulation, such as adding emollients or .. buffers, can alter the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/78N-0064-gdl0002.pdf (score=95)

Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and...
...Under the Pediatric Rule you may be required to produce a pediatric formulation if one is.....It is usually prudent to begin the development of a pediatric formulation before.....FDA can waive the requirement for pediatric studies in age groups requiring a pediatric..
http://www.fda.gov/cder/guidance/3578dft.htm (score=93)

...Under the Pediatric Rule you may be required to produce a pediatric formulation if one is.....It is usually prudent to begin the development of a pediatric formulation before.....FDA can waive the requirement for pediatric studies in age groups requiring a pediatric..
http://www.fda.gov/cder/guidance/3578dft.doc (score=93)

NEW TYPHOID VACCINE LICENSED
...The efficacy of the licensed liquid formulation of this vaccine was assessed in a.....Also considered in assessing the licensed formulation's efficacy were the results of a.....formulation of typhoid Vi polysaccharide vaccine. In this randomized, double- blind, well..
http://www.fda.gov/bbs/topics/ANSWERS/ANS00618.html (score=92)

...There is no marketable 16 age-appropriate formulation for children 6 months 17 to 6 years.....We will 17 verify this but I think the point was that because 18 there was no formulation.....5 We have heard two presentations where there has 6 been a lack of an adequate formulation..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4050T1.DOC (score=88)

MDI and DPI Drug Products
...an internal reservoir containing sufficient formulation for multiple doses that are.....formulation, moisture level, consistency of filling operation, particle size distribution.....DPIs, the formulation, and the device with all of its parts including any protective..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=131)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The composition of an MDI formulation and the physicochemical content of each of the.....Is a sophisticated formulation of the drug product required to ensure dosing accuracy and.....Because of the sophisticated formulation, is product-to-product uniformity of the drug..
http://www.fda.gov/cder/fdama/difconc.htm (score=115)

þÿ
...formulation of bupropion in smoking cessation trials, as well as the immediate-release.....given twice daily, and the immediate-release formulation of bupropion, given three times.....the effectiveness of the immediate-release formulation of bupropion on the HDRS total..
http://www.fda.gov/cder/foi/label/2002/20358s27lbl.pdf (score=110)

/a/content.2223
...involving the sustained-release formulation of bupropion resulted from the different.....immediate-release formulation of bupropion at 100 mg three times daily, peak plasma.....state, WELLBUTRIN SR Tablets, given twice daily, and the immediate-release formulation of..
http://www.fda.gov/cder/ogd/rld/20358s16.pdf (score=106)

Safety and Effectiveness of New Drugs & Biological Products in Pediatric...
...Failure to develop a pediatric formulation of a drug, where younger pediatric populations.....If a waiver were granted on the ground that it was not possible to develop a pediatric.....The need to develop a pediatric formulation does not necessarily mean that the product..
http://www.fda.gov/cder/guidance/pedrule.htm (score=97)

Budget Formulation and Presentation
...The staff performs all duties involved with the formulation and presentation of budget.....Facilitates the formulation and presentation of all external resource requests in.....Budget Formulation and Presentation.. Budget Formulation plans, organizes, and carries out annual and multi-year budgeting in..
http://www.fda.gov/oc/oms/ofm/budget/formulation.htm (score=96)

...Because minor variations in formulation, such as adding emollients or buffers, can alter.....Except for the active ingredient, the placebo control formulation should be as similar as.....formulation to one axilla and the application of a placebo control formulation to the..
http://www.fda.gov/OHRMS/DOCKETS/98fr/78N-0064-gdl0002.doc (score=95)

FR Doc 03-14140
...Subjects applied the antiperspirant test formulation to one axilla and used either a.....The placebo was identical to the test formulation and supposedly devoid of antiperspirant.....The proposed guidelines stated that the control formulation is as similar as possible to..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=94)

QUESTIONS TO THE COMMITTEE
...To establish bioequivalence of suspension formulation nasal aerosols and nasal sprays for.....local delivery of suspension formulation nasal sprays and nasal aerosols for..allergic.....delivery of suspension formulation nasal sprays and nasal aerosols for allergic..rhinitis..
http://www.fda.gov/ohrms/dockets/ac/01/questions/3764q1.pdf (score=93)

WAIS Document Retrieval
...The potential for titanium dioxide particles to agglomerate in formulation, which could.....The agency recognizes that technological advances in sunscreen formulation technology.....Due to the recent advances in sunscreen formulation and the data referenced previously..
http://www.fda.gov/cder/fdama/fedreg/sunscreen.txt (score=92)

/a/content.5141
...daily, and the immediate-release formulation of bupropion, given three times daily, are.....demonstrated the effectiveness of the immediate-release formulation of bupropion on the.....demonstrated the effectiveness of the immediate-release formulation of bupropion, but only..
http://www.fda.gov/cder/foi/label/2001/20358s19lbl.pdf (score=92)

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