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From page 231... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/ nda/2002/21-373_Ibuprofen%20Pseudoephedrine_biopharmr.pdf (accessed March 23, 2012) Read the entire page →
From page 232... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/UCM195876.pdf (accessed March 23, 2012) Read the entire page →
From page 233... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/ucm074348.pdf (accessed March 23, 2012) Read the entire page →
From page 234... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/ 021511s023,103964s5213ltr.pdf (accessed March 23, 2012) Read the entire page →
From page 235... ... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Pediatric AdvisoryCommittee/UCM272409.pdf (accessed March 23, 2012) Read the entire page →
From page 236... ... http://www.ofirmev.com/pdf/OFIRMEVPrescribing Information.pdf (accessed March 23, 2012) Read the entire page →
From page 237... ... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM227351.pdf (accessed March 23, 2012) Read the entire page →
From page 238... ... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Development Resources/UCM195520.pdf (accessed March 23, 2012) Read the entire page →
From page 239... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/AdvisoryCommittees /CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee /UCM225329.pdf (accessed March 23, 2012) Read the entire page →
From page 240... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071957.pdf (accessed March 23, 2012) Read the entire page →
From page 241... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/drugs/development approvalprocess/developmentresources/ucm049915.pdf (accessed March 23, 2012) Read the entire page →
From page 242... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/ downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf (accessed March 23, 2012) Read the entire page →
From page 243... ... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM235453.pdf (accessed March 23, 2012) Read the entire page →
From page 244... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_ docs/appletter/2004/21144ltr.pdf (accessed March 23, 2012) Read the entire page →
From page 245... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21 598_Vigamox_medr.PDF (accessed April 3, 2012) Read the entire page →
From page 246... ... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM073122.pdf (accessed April 3, 2012) Read the entire page →
From page 247... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter /2009/021001s010,s011ltr.pdf (accessed April 3, 2012) Read the entire page →
From page 248... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsat fda_docs/appletter/2009/022037s000ltr.pdf (accessed April 3, 2012) Read the entire page →
From page 249... ... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Licensed ProductsBLAs/FractionatedPlasmaProducts/ucm134046.htm (accessed April 3, 2012) Read the entire page →
From page 250... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/UCM258689.pdf (accessed April 3, 2012) Read the entire page →
From page 251... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_ docs/appletter/2008/021976s009ltr.pdf (accessed April 3, 2012) Read the entire page →
From page 252... ... Bethesda, MD: National Institute of Child Health and Human Development. http://bpca.nichd.nih.gov/collaborativeefforts/upload/2008_bpca_ scientific_prioritization_meeting_minutes.pdf (accessed April 3, 2012) Read the entire page →
From page 253... ... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Pediatric AdvisoryCommittee/UCM198447.pdf (accessed April 3, 2012) Read the entire page →
From page 254... ... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Development Resources/UCM197636.pdf (accessed April 3, 2012) Read the entire page →
From page 255... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugs atfda_docs/appletter/2011/022510s000ltr.pdf (accessed April 3, 2012) Read the entire page →
From page 256... ... 2011. Clinical review for adenovirus type 4 and type 7 vaccine, live, oral enteric coated tablets biologics license application. Read the entire page →
From page 257... ... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Development Resources/UCM071555.pdf (accessed April 3, 2012) Read the entire page →
From page 258... ... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugs atfda_docs/appletter/2010/022563s000ltr.pdf (accessed April 3, 2012) Read the entire page →
From page 259... ... 2008. Clinical review for Ventolin HFA (albuterol sulfate HFA inhalation aerosol) Read the entire page →
From page 260... ... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM249246.pdf (accessed April 3, 2012) Read the entire page →

From page 231...

... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/ nda/2002/21-373_Ibuprofen%20Pseudoephedrine_biopharmr.pdf (accessed March 23, 2012)

References Pages 231-260

References
Pages 231-260