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Food and Drug Administration / Organ transplants / Medical research / Drug discovery / Islet cell transplantation / Diabetes management / Diabetes mellitus type 1 / Insulin therapy / Islets of Langerhans / Medicine / Biology / Diabetes


Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
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City

Rockville / /

Company

Manufacturing Process Manufacturing / A. Demonstrating Quality Source Material Health Resources / /

Facility

Rockville Pike / /

IndustryTerm

manufacturing facility / allogeneic islet cell product / biological products / manufacturing controls / allogeneic pancreatic islet cell products / islet cell product / biological product / allogeneic islet cell products / degradation products / modified allogeneic islet cell products / final allogeneic islet cell product / manufacturing islets / allogeneic islet product / aseptic processing / islet cell products / clinical trial protocol / final product / manufacturing consistency / manufacturing change / final encapsulated islet product / manufacturing practice regulations / manufacturing steps / manufacturing / encapsulated islet products / be manufactured using aseptic processing / /

MedicalCondition

cholecystitis / basal cell carcinoma / active ulcer disease / hepatitis C / hepatitis B / intensive diabetes / diabetic ketoacidosis / well-documented chronic history / hypoglycemia / dissociation / disease / organ fibrosis / cervical carcinoma / diabetes-related complications / qualified diabetes / diabetes / hyperlipidemia / Chronic infections / portal hypertension / diabetes mellitus / pancreatitis / coronary artery disease / severe hypoglycemia / tuberculosis / /

MedicalTreatment

insulin therapy / immunosuppression / kidney transplant / organ transplant / /

Organization

Cellular / Tissue / and Gene Therapies Advisory Committee / office of Communication / Outreach and Development / Demonstrating Quality Source Material Health Resources and Services Administration / Food and Drug Administration / Biological Response Modifiers Advisory Committee / U.S. Department of Health and Human Services Food and Drug Administration Center / Services Administration / /

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Position

General / representative / /

ProvinceOrState

A. B. / /

Technology

antibodies / clinical trial protocol / transplantation / processing algorithm / pdf / Gene Therapy / 6 CLINICAL STUDY PROTOCOLS / CLINICAL STUDY PROTOCOLS / /

URL

http /

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