Guidance for industry : compliance with 21 CFR part 1271.150(c)(1), manufacturing arrangements.
| Corporate Author: | Center for Biologics Evaluation and Research (U.S.) |
|---|---|
| Format: | Government Document eBook |
| Language: | English |
| Published: |
Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,
[2006]
|
| Subjects: | |
| Online Access: | https://purl.fdlp.gov/GPO/LPS112732 |
Similar Items
Guidance for industry and staff : minimal manipulation of structural tissue jurisdictional update.
Published: (2006)
Published: (2006)
Guidance for industry : MedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Published: (2005)
Published: (2005)
Guidance for industry : regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) : small entity compliance guide.
Published: (2007)
Published: (2007)
Guidance for industry and FDA staff : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Published: (2007)
Published: (2007)
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).
Published: (2009)
Published: (2009)
Guidance for industry : validation of procedures for processing of human tissues intended for transplantation.
Published: (2002)
Published: (2002)
Guidance for industry : guidance for human somatic cell therapy and gene therapy.
Published: (1998)
Published: (1998)
Culture of cells for tissue engineering /
Published: (2006)
Published: (2006)
Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation.
Published: (2001)
Published: (2001)
Fetal tissue : is it being sold in violation of federal law? : hearing before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives, One Hundred Sixth Congress, second session, March 9, 2000.
Published: (2000)
Published: (2000)
Fetal tissue : is it being sold in violation of federal law? : hearing before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives, One Hundred Sixth Congress, second session, March 9, 2000.
Published: (2000)
Published: (2000)
Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms.
Published: (2001)
Published: (2001)
Guidance for industry : somatic cell therapy for cardiac disease.
Published: (2009)
Published: (2009)
The cultivation of animal and plant cells /
by: White, Philip R. (Philip Rodney), 1901-
Published: (1963)
by: White, Philip R. (Philip Rodney), 1901-
Published: (1963)
Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records.
Published: (2002)
Published: (2002)
Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators.
Published: (2007)
Published: (2007)
Donated organ allocation policy : hearing before a subcommittee of the Committee on Appropriations, United States Senate; One Hundred Sixth Congress, first session; special hearing.
Published: (2000)
Published: (2000)
Donated organ allocation policy : hearing before a subcommittee of the Committee on Appropriations, United States Senate, One Hundred Sixth Congress, first session, special hearing.
Published: (2000)
Published: (2000)
Animal cell culture : a practical approach /
Published: (1992)
Published: (1992)
Guidance for industry : implementing a collection program for source plasma containing disease-associated and other immunoglobulin G (IgG) antibodies.
Published: (2006)
Published: (2006)
Guidance for industry : eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Published: (2007)
Published: (2007)
Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance.
Published: (2004)
Published: (2004)
Increasing the supply of human organs : three policy proposals /
by: Crowe, Sam
Published: (2007)
by: Crowe, Sam
Published: (2007)
Engineering Neural Tissue from Stem Cells /
by: Willerth, Stephanie
Published: (2017)
by: Willerth, Stephanie
Published: (2017)
Guidance for industry : independent consultants for biotechnology clinical trial protocols.
Published: (2004)
Published: (2004)
The urgent need to reform the organ transplantation system to secure more organs for waiting, ailing, and dying patients : hearing before the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform, House of Representatives, One Hundred Seventeenth Congress, first session, May 4, 2021.
Published: (2021)
Published: (2021)
Guidance for industry : guidance on the labeling of certain uses of Lecithin derived from soy under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
Published: (2006)
Published: (2006)
Guidance for industry : Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps).
Published: (2009)
Published: (2009)
Principles of tissue engineering /
Published: (2007)
Published: (2007)
Readings in mammalian cell culture.
by: Pollack, Robert, 1926-
Published: (1973)
by: Pollack, Robert, 1926-
Published: (1973)
Principles of tissue engineering /
Published: (2014)
Published: (2014)
Guidance for industry : part 11, electronic records : electronic signatures--scope and application.
Published: (2003)
Published: (2003)
Methods in cell biology.
Published: (1980)
Published: (1980)
Guidance for industry : good pharmacovigilance practices and pharmacoepidemiologic assessment.
Published: (2005)
Published: (2005)
Plant tissue culture and plant morphogenesis. : (Kultura izolirovannykh tkanei i fibiologiya morfogeneza rastenii) /
by: Butenko, R. G. (Raisa Georgievna)
Published: (1968)
by: Butenko, R. G. (Raisa Georgievna)
Published: (1968)
Culture of animal cells : a manual of basic technique /
by: Freshney, R. Ian
Published: (1994)
by: Freshney, R. Ian
Published: (1994)
Culture of animal cells : a manual of basic technique /
by: Freshney, R. Ian
Published: (1987)
by: Freshney, R. Ian
Published: (1987)
Guidance for industry : public health issues posed by the use of nonhuman primate xenografts in humans.
Published: (1999)
Published: (1999)
Guidance for industry : ANDAs, pharmaceutical solid polymorphism, chemistry, manufacturing and controls information.
Published: (2007)
Published: (2007)
Guidance for industry : availability of licensed donor screening tests labeled for use with cadaveric blood specimens.
Published: (2000)
Published: (2000)