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Guidance for Industry Clinical Lactation Studies – Study Design, Data Analysis, and Recommendations for Labeling DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.
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City

Berlin / Rockville / Neville / /

Company

DHHS Services / Pregnancy Working Group / AAP Work Group / /

Country

United States / /

Event

FDA Phase / /

Facility

Rockville Pike / /

IndustryTerm

migraine therapy / biological products / pharmaceuticals / term medical product / chemical exposures / drug products / chemicals / /

MedicalCondition

chronic maternal conditions / rare diseases / chronic dosing / ear infections / migraine / respiratory infections / pain / multiple sclerosis / osteoporosis / diarrhea / premenopausal breast cancer / /

MedicalTreatment

drug therapy / /

Organization

U.S. Department of Health and Human Services / World Health Organization / Training and Communications Division of Drug Information / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / AAP Committee on Drugs / Division of Dockets Management / office of Training / US Federal Reserve / European Centre for Environment and Health / HFD-240 Center for Drug Evaluation / HFM-40 Center for Biologics Evaluation / American Academy of Pediatrics / Pregnancy Labeling Task Force / Center for Biologics Evaluation and Research / office of Communication / Training and Manufacturers Assistance / /

Person

Toni M. Stifano / Wide / Kathleen Uhl / /

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Product

Shure E2c Headphone/Headset / information / unbound drug / /

ProvinceOrState

Maryland / /

Technology

Pharmacokinetics / pharmacodynamics / anti-infectives / /

URL

http /

SocialTag