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Enzymes / Hydrolases / Food and Drug Administration / Pharmacology / Pharmaceutical industry / Papain / Proteases / New Drug Application / Generally recognized as safe and effective / Medicine / Health / Pharmaceutical sciences


Document Date: 2008-09-19 15:55:46

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City

OB / /

Company

Goldman / Marketed Unapproved Drugs CPG / Sage Pharmaceuticals / /

Country

United States / /

/

Event

Reorganization / FDA Phase / Second Stock Issuance / /

IndustryTerm

papain-containing topical drug products / Topical drug products / unapproved drug product / unapproved topical papain drug products / contact lens solution / topical papain drug products / activity involving retail / notice that any product / papain drug products / topical papain products / unapproved topical drug product / papain-containing products / Drug manufacturers / topical products / manufacturing practices / unapproved topical product / topical drug product / topical product / manufacturing / unapproved topical drug products / food industry / drug products / or ships such products / /

MedicalCondition

anaphylactic shock / local inflammation / anaphylaxis / pressure ulcers / allergy / seizure / acute and chronic lesions / hypersensitivity / varicose ulcers / /

Organization

Enforcement Action Dates AGENCY / office of New Drugs / Food and Drug Administration / office of Compliance / Division of Dermatology and Dental Products / Division of New Drugs and Labeling Compliance / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH AND HUMAN SERVICES Display Date / /

Person

Silver Spring / /

/

Position

Governor / Deputy Commissioner for Policy / chief executive officer / Commissioner for Policy and Planning / /

Product

unapproved drug / /

ProvinceOrState

South Carolina / Maryland / /

PublishedMedium

the FDA Staff Manual Guide / /

URL

http /

SocialTag