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).

Germ cells and soma : a new look at an old problem /
by: McLaren, Anne
Published: (1981)

Hybridization of somatic cells.
by: Ephrussi, Boris, 1901-1979
Published: (1972)

Somatic cell hybridization /
Published: (1974)

Somatic cells and milk of small ruminants : proceedings of the Symposium on Somatic Cells and Milk of Small Ruminants, Bella, Italy, 25-27 September 1993 /
Published: (1996)

Overview of the role of somatic cell nuclear transfer (Scnt) in stem cell research.
Published: (2020)

Drugs@FDA.

Guidance for industry and FDA staff : how to write a request for designation (RFD).
Published: (2005)

Cell hybrids /
by: Ringertz, Nils R., 1903-
Published: (1976)

Somatic embryogenesis /
Published: (2006)

FDA's drug review process and the package label : strategies for writing successful FDA submissions /
by: Brody, Tom
Published: (2017)

Guidance for industry and FDA staff : submission and resolution of formal disputes regarding the timeliness of premarket review of a combination product.
Published: (2004)

Guidance for FDA staff and industry : marketed unapproved drugs, compliance policy guide.
Published: (2006)

Guidance for industry : format and content for the CMC section of an annual report.
Published: (1994)

Guidance for industry : major, minor, and telephone amendments to abbreviated new drug applications.
Published: (2001)

Guidance for industry : variations in drug products that may be included in a single ANDA.
Published: (1998)

Somatic cell nuclear transfer /
Published: (2006)

Recovery and evaluation of somatic cells from ovine and bovine semen for use in nuclear transfer /
by: Liu, Jie
Published: (2010)

FDA's review process for new drug applications : a management review.
Published: (2003)

Artificial cells, cell engineering and therapy /
Published: (2007)

Somatic cell hybrids : the basics /
by: Abbott, Catherine M.
Published: (1995)

Guidance for industry : changes to an approved NDA or ANDA.
Published: (2004)

Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.
Published: (2001)

Guidance for industry : changes to an approved NDA or ANDA, questions and answers.
Published: (2001)

Guidance for industry : Q3A impurities in new drug substances.
Published: (2008)

Guidance for industry : NDA's : impurities in drug substances.
Published: (2000)

Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
Published: (2004)

Guidance for industry : formal meetings between the FDA and sponsors or applicants.
Published: (2009)

Guidance for industry : referencing discontinued labeling for listed drugs in abbreviated new drug applications.
Published: (2000)

Guidance for industry and FDA staff : application user fees for combination products.
Published: (2005)

Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.
Published: (2003)

Guidance for industry : comparability protocols, chemistry, manufacturing, and controls information.
Published: (2003)

Somatic embryogenesis and gene expression /
Published: (2013)

CAR T cells : development, characterization and applications /
Published: (2022)

Somatic embryogenesis in ornamentals and its applications /
Published: (2016)

Protocol for somatic embryogenesis in woody plants /
Published: (2005)

Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.
Published: (2001)