| Document Date: 2006-03-17 17:30:57
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City Rockville / Deerfield / / Company BP / Pharmaceutical Scientist Inc / / / Event FDA Phase / / / IndustryTerm sufficient tools / important tools / biogeneric manufacturing facilities / recombinant products / case law / upstream processing / Biological products / mean equivalent product / biogeneric manufacturer / final product / protein product / biotechnology / recombinant therapeutic protein products / Appropriate protocols / analytical technology / follow-on protein product / protein products / downstream processing / derived products / biogeneric product / manufacturing / comparability protocol / non-biological products / to biogeneric products / biogeneric products / closure systems / endogenous product / to biological products / manufacturing process / / MedicalCondition autoimmune disorders / MS / / Organization Cricket Board / Food and Drug Administration / Division of Dockets Management / / Person Sarfaraz Niazi Sarfaraz / / / Position CEO / / Product Comparability / / ProvinceOrState Maryland / Illinois / / Technology comparability protocol / biotechnology / extended protocol / /
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20 September, 2004 Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD[removed]Subject: Scientific Considerations Related to Developing Follow-On Protein Prod