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Health / Medicine / Clinical pharmacology / Therapeutics / United States Public Health Service / FDA Fast Track Development Program / New Drug Application / Food and Drug Administration / Pharmaceutical sciences / Pharmacology


Successfully Moving Forward with IND and NDA Submissions for Breakthrough Drugs
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IndustryTerm

drug product / manufacturing development / manufacturing development programs / manufacturing sites / treatment of a serious or life-threatening disease / manufacturing scale / manufacturing program / rapid manufacturing development program / /

MedicalCondition

disease / /

MusicGroup

Ph.D. / /

Organization

FDA / /

Person

Miksinski / /

Position

Acting Director / Division / Director / Division of New Drug Quality Assessment / /

ProgrammingLanguage

DC / /

ProvinceOrState

Indiana / /

Technology

http / /

URL

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf / /

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