Health care IT 2016 : new technology, new legal issues /Publisher: New York, New York : Practising Law Institute,
Date: [2016] This title can be found in 1 Iowa libraries.
Health care and life sciences law, 2014 /Publisher: New York, New York : Practising Law Institute,
Date: [2014] This title can be found in 1 Iowa libraries.
Developments in pharmaceutical and biotech patent law, 2013 /Publisher: New York, NY : Practising Law Institute,
Date: [2013] This title can be found in 1 Iowa libraries.
Guidance for industry submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2010] This title can be found in 2 Iowa libraries.
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4B,Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry assay development for immunogenicity testing of therapeutic proteins.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry label comprehension studies for nonprescription drug products : draft guidance.Format: [electronic resource] :
Publisher: [Beltsville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry standards for securing the drug supply chain : standardized numerical identification for prescription drug packages.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner :
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry formal meetings between the FDA and sponsors or applicants.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry dosage delivery devices for OTC liquid drug products.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
Date: [2009] This title can be found in 1 Iowa libraries.
Assay migration studies for in vitro diagnostic devicesFormat: [electronic resource].
Publisher: [Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety ;
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry postmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4A,Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.Format: [electronic resource] :
Publisher: Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ;
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry Q10 pharmaceutical quality system.Format: [electronic resource] :
Publisher: Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ;
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry use of serological tests to reduce the risk of transmission of trypanosoma cruzi infection in whole blood and blood components for transfusion and human cells, tissues, and cellular and tissue-based products (HCT/Ps).Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
Date: [2009] This title can be found in 2 Iowa libraries.
Guidance for industry drug-induced liver injury, premarketing clinical evaluation.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry pharmaceutical components at risk for melamine contamination.Format: [electronic resource] :
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :
Date: [2009] This title can be found in 1 Iowa libraries.
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