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Federal Register / Vol. 73, No[removed]Friday, February 8, [removed]Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0014]
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Document Date: 2008-02-08 07:59:48


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Company

Marketed Unapproved Drugs CPG / the AES / /

Country

United States / /

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Event

FDA Phase / Reorganization / /

Facility

Pharmacy Compounding / Pharmacy Compounding CPG / /

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IndustryTerm

injection products / unapproved drug product / colchicine products / injectable drug product / notice that any product / Drug manufacturers / unapproved injectable colchicine products / manufacturing practices / unapproved injectable colchicine product / manufacturing / injection product / unapproved drug products / ceased manufacturing colchicine / or ships such products / /

MedicalCondition

abdominal pain / paralysis / seizures / neutropenia / acute renal failure / nausea / alopecia / peripheral neuropathy / rhabdomyolysis / seizure / leukocytosis / cardiac arrhythmia / vomiting / gout / recovery phase involving leukocytosis / diarrhea / thrombocytopenia / congestive heart failure / renal failure / back pain / pancytopenia / respiratory distress / acute gout / /

MedicalTreatment

alternative therapies / /

Movie

A.D. / /

Organization

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / office of Planning / FDA / and Drug Administration Risk Communication Advisory Committee / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Risk Communication Advisory Committee / Center for Drug Evaluation and Research / U.S. Securities and Exchange Commission / Meeting AGENCY / /

Person

Jeffrey Shuren / Lee L. Zwanziger / Silver Spring / /

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Position

Governor / Deputy Commissioner for Policy / chief executive officer / Commissioner / Assistant Commissioner for Policy / General / /

Product

probenecid / for / unapproved drug / /

ProgrammingLanguage

DC / C / /

ProvinceOrState

Maryland / /

PublishedMedium

the FDA Staff Manual Guide / /

SocialTag