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Items: 1 to 20 of 330

1.

FDA regulation of stem cell-based products.

Fink DW Jr.

Science. 2009 Jun 26;324(5935):1662-3. doi: 10.1126/science.1173712.

PMID:
19556496
2.

Stem-cell-derived products: an FDA update.

Moos M Jr.

Trends Pharmacol Sci. 2008 Dec;29(12):591-3. doi: 10.1016/j.tips.2008.09.003. Epub 2008 Oct 18.

PMID:
18937983
3.

FDA regulation of stem-cell-based therapies.

Halme DG, Kessler DA.

N Engl J Med. 2006 Oct 19;355(16):1730-5. No abstract available.

4.

The FDA's role in medical device clinical studies of human subjects.

Saviola J.

J Neural Eng. 2005 Mar;2(1):S1-4. Epub 2005 Feb 22. Review.

PMID:
15876645
5.

Product regulation and the clinical translation of stem cell research.

von Tigerstrom B.

Stem Cell Rev. 2009 Jun;5(2):135-9. doi: 10.1007/s12015-009-9059-z. Epub 2009 Mar 4. Review.

PMID:
19259831
6.

Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges.

Hyun I.

J Law Med Ethics. 2010 Summer;38(2):277-85. doi: 10.1111/j.1748-720X.2010.00488.x.

PMID:
20579251
7.

FDA regulations for growth factors and related products.

Chapekar MS, Gunter KC.

EXS. 1992;61:471-8.

PMID:
1617242
8.

Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

Mathews DJ, Sugarman J, Bok H, Blass DM, Coyle JT, Duggan P, Finkel J, Greely HT, Hillis A, Hoke A, Johnson R, Johnston M, Kahn J, Kerr D, Kurtzberg J, Liao SM, McDonald JW, McKhann G, Nelson KB, Rao M, Regenberg A, Siegel AW, Smith K, Solter D, Song H, Vescovi A, Young W, Gearhart JD, Faden R.

Neurology. 2008 Jul 22;71(4):288-93. doi: 10.1212/01.wnl.0000316436.13659.80. Epub 2008 May 7. Review.

PMID:
18463365
9.

Monitoring of clinical investigations; availability of guideline--FDA. Notice.

[No authors listed]

Fed Regist. 1988 Feb 17;53(31):4723-4.

PMID:
10285639
10.

Current regulatory issues in cell and tissue therapy.

Burger SR.

Cytotherapy. 2003;5(4):289-98. Review.

PMID:
12944234
11.

Hazard identification and risk assessment for biologics targeting the immune system.

Weir AB.

J Immunotoxicol. 2008 Jan;5(1):3-10. doi: 10.1080/15476910801897409. Review.

PMID:
18382852
12.

Unique/major human metabolites: why, how, and when to test for safety in animals.

Luffer-Atlas D.

Drug Metab Rev. 2008;40(3):447-63. doi: 10.1080/03602530802186561 . Review.

PMID:
18642142
13.
14.

FDA oversight of cell therapy clinical trials.

Au P, Hursh DA, Lim A, Moos MC Jr, Oh SS, Schneider BS, Witten CM.

Sci Transl Med. 2012 Aug 29;4(149):149fs31. doi: 10.1126/scitranslmed.3004131.

PMID:
22932219
15.

FDA to vet embryonic stem cells' safety.

Baker M.

Nature. 2008 Apr 10;452(7188):670. doi: 10.1038/452670a. No abstract available.

PMID:
18401364
16.

Health risk assessment practices in the U.S. Food and Drug Administration.

Gaylor DW, Axelrad JA, Brown RP, Cavagnaro JA, Cyr WH, Hulebak KL, Lorentzen RJ, Miller MA, Mulligan LT, Schwetz BA.

Regul Toxicol Pharmacol. 1997 Dec;26(3):307-21. Review.

PMID:
9441921
17.

Translating stem cell research: challenges at the research frontier.

Magnus D.

J Law Med Ethics. 2010 Summer;38(2):267-76. doi: 10.1111/j.1748-720X.2010.00487.x.

PMID:
20579250
18.

FDA regulatory pathways for knee cartilage repair products.

Levine DW, Mondano L, Halpin M.

Sports Med Arthrosc. 2008 Dec;16(4):202-7. doi: 10.1097/JSA.0b013e31818cdb97. Review.

PMID:
19011551
19.

Stem cells. U.S. regulation of stem cells as medical products.

Sipp D, Turner L.

Science. 2012 Dec 7;338(6112):1296-7. doi: 10.1126/science.1229918. No abstract available.

PMID:
23224541
20.

Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States.

Lee MH, Arcidiacono JA, Bilek AM, Wille JJ, Hamill CA, Wonnacott KM, Wells MA, Oh SS.

Tissue Eng Part B Rev. 2010 Feb;16(1):41-54. doi: 10.1089/ten.TEB.2009.0449. Review.

PMID:
19728784

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