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Biology / Botulinum toxin / Structured Product Labeling / Allergan / Botulism / Spasmodic torticollis / Federal Food / Drug / and Cosmetic Act / Center for Drug Evaluation and Research / Biologic License Application / Medicine / Food and Drug Administration / Health


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Document Date: 2009-08-07 11:32:47

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File Size: 271,76 KB

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City

Beltsville / Dupont Drive Irvine / /

Company

Allergan Inc. / /

Event

FDA Phase / /

Facility

National Library of Medicine / /

/

IndustryTerm

therapeutic biological products / Final printed advertising / botulinum toxin products / revised approved product / marketed botulinum toxin products / licensed botulinum toxin products / healthcare providers / botulinum toxin product / /

MedicalCondition

cervical dystonia / dysphagia / MS / /

MedicalTreatment

medication errors / Botox / /

Organization

Food and Drug Administration / Division of Dermatology / Division of Drug Marketing / Advertising / and Communications / Center for Drug Evaluation and Research / Neurology Products Office / Center for Drug Evaluation and Research Enclosures / DEPARTMENT OF HEALTH / Dermatology and Dental Products Office / /

Person

Russell Katz / Melina M. Dass / Susan Walker / Tamy Kim / /

/

Position

Senior Regulatory Project Manager / Director / Manager Regulatory Operations and Intelligence / Director Division / /

Product

Botox Cosmetic / Federal Food / NEW SUPPLEMENT / new / PROPOSED REMS MODIFICATION REMS ASSESSMENT NEW SUPPLEMENT / /

ProvinceOrState

Maryland / California / /

PublishedMedium

the Medication Guide / /

URL

http /

SocialTag