Call Number (LC) Title Results
HE 20.4716: Drugs@FDA 1
HE 20.4717: News along the pike 1
HE 20.4801 Annual report 1
HE 20.4801: Report to the biologics community
FY ... report from the director.
Annual report 		4
HE 20.4802:AL 5 Guidance for industry considerations for allogeneic pancreatic islet cell products. 1
HE 20.4802:AN 1 Guidance for industry and FDA staff commercially distributed analyte specific reagents (ASRs), frequently asked questions. 1
HE 20.4802:AN 5 Guidance for industry animal models : essential elements to address efficacy under the animal rule. 1
HE 20.4802:AN 5/2 Animal models essential elements to address efficacy under the animal rule. 1
HE 20.4802:AN 5/3 Guidance for industry source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans. 1
HE 20.4802:AN 8 S9 nonclinical evaluation for anticancer pharmaceuticals 1
HE 20.4802:AU 8 Guidance for industry and FDA staff class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle. 1
HE 20.4802:B 52 Guidance for industry manufacturing biological intermediates and biological drug substances using spore-forming microorganisms.
Guidance for industry changes to an approved application for specified biotechnology and specified synthetic biological products. 		2
HE 20.4802:B 52/2 Guidance for industry biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components. 1
HE 20.4802:B 52/3 Guidance for industry biological product deviation reporting for blood and plasma establishments. 1
HE 20.4802:B 52/4 Guidance for industry changes to an approved application : biological products, human blood and blood components intended for transfusion or for further manufacture. 1
HE 20.4802:B 52/5 Guidance for industry changes to an approved application for specified biotechnology and specified synthetic biological products. 1
HE 20.4802:B 52/DRAFT Guidance for industry drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals. 1
HE 20.4802:B 62 Guidance for industry blood establishment computer system validation in the user's facility. 1
HE 20.4802:B 62/2 Guidance for industries variances for blood collection from individuals with hereditary hemochromatosis. 1
HE 20.4802:C 17 Guidance for industry S1C(R2) dose selection for carcinogenicity studies. 1