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Pharmaceutical industry / Research / Clinical research / Drug safety / New Drug Application / Nizatidine / Prison Rape Elimination Act / Pharmaceutical sciences / Pharmacology / Food and Drug Administration


PREA Non-Compliance Letter N021494-000
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Company

Braintree Laboratories Inc. / /

Event

FDA Phase / /

IndustryTerm

federal law / /

Organization

Division of Gastroenterology / Gastroenterology and Inborn Errors Products Office / Center for Drug Evaluation and Research / Food and Drug Administration / DEPARTMENT OF HEALTH AND HUMAN SERVICES / /

Person

Silver Spring / Donna Griebel / Elizabeth Ford / /

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Position

Vivian Caballero Vice President / Regulatory Affairs / Regulatory Project Manager / Director / M.D. Director / /

Product

Axid / nizatidine / Federal Food / /

ProvinceOrState

Indiana / Massachusetts / /

URL

http /

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