Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop /Publisher: Washington, D.C. : National Academies Press,
Date: c2010 This title can be found in 1 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.
New drug approval FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints : report to the Ranking Member, Committee on Finance, U.S. Senate.Format: [electronic resource] :
Publisher: [Washington, D.C.] : U.S. Govt. Accountability Office,
Date: [2009] This title can be found in 1 Iowa libraries.
Guidance for industry ANDAs, impurities in drug substances.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.
E 16 genomic biomarkers related to drug response context, structure, and format of qualification submissions.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.
User fees and refunds for premarket approval applicationsFormat: [electronic resource].
Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health :
Date: [2009] This title can be found in 2 Iowa libraries.
Before Prozac : the troubled history of mood disorders in psychiatry /Author: Shorter, Edward.
Publisher: New York : Oxford University Press,
Date: 2009. This title can be found in 8 Iowa libraries.
New medicines : issues of approval, access, and product safety /Author: Harmon, Daniel E.
Publisher: New York, NY : Rosen Pub. Group,
Date: 2009. 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: Silver, Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ;
Date: [2008] This title can be found in 2 Iowa libraries.
Guidance for GDA reviews and sponsors content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).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: [2008] This title can be found in 1 Iowa libraries.
Guidance for industry providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.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: [2008] This title can be found in 2 Iowa libraries.
Guidance for industry Q3A impurities in new drug substances.Format: [electronic resource] :
Publisher: Sliver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ;
Date: [2008] This title can be found in 2 Iowa libraries.
An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the Animal Drug User Fee Program, to Establish a Program of Fees Relating to Generic New Animal Drugs, to Make Certain Technical Corrections to the Food and Drug Administration Amendments Act of 2007, and for Other PurposesFormat: [electronic resource].
Publisher: [Washington, D.C. : U.S. G.P.O.,
Date: 2008] This title can be found in 1 Iowa libraries.
Guidance for FDA reviews and sponsors content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).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: [2008] This title can be found in 2 Iowa libraries.
Ketek clinical study fraud what did Aventis know? : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, February 12, 2008.Format: [electronic resource] :
Publisher: Washington : U.S. G.P.O.,
Date: 2008. This title can be found in 1 Iowa libraries.
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics /Publisher: New York : Informa Healthcare USA,
Date: c2008. This title can be found in 1 Iowa libraries.
Ketek clinical study fraud what did Aventis know? : hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, second session, February 12, 2008.Format: [microform] :
Publisher: Washington : U.S. G.P.O. :
Date: 2008. This title can be found in 1 Iowa libraries.
Pharmaceutical pre-approval inspections : a guide to regulatory success /Publisher: New York : Informa Healthcare,
Date: [2008] This title can be found in 1 Iowa libraries.
Guidance for industry antibacterial drug products, use of noninferiority studies to support approval.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: [2007] This title can be found in 1 Iowa libraries.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.