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1.

Off-label use of medical products in radiation therapy: summary of the report of AAPM Task Group No. 121.

Thomadsen BR, Heaton HT 2nd, Jani SK, Masten JP, Napolitano ME, Ouhib Z, Reft CS, Rivard MJ, Robin TT, Subramanian M, Suleiman OH.

Med Phys. 2010 May;37(5):2300-11.

PMID:
20527564
2.

Off-label use of medical devices in radiology: regulatory standards and recent developments.

Smith JJ.

J Am Coll Radiol. 2010;7(2):115-9. doi: 10.1016/j.jacr.2009.09.025.

PMID:
20142085
4.

Enforcement related to off-label marketing and use of drugs and devices: where have we been and where are we going?

Joseph JN, Deaton D, Ehsan H, Bonanno MA.

J Health Life Sci Law. 2009 Jan;2(2):73-108.

PMID:
19288889
7.

FDA medical device approval: things you didn't learn in medical school or residency.

Buch B.

Am J Orthop (Belle Mead NJ). 2007 Aug;36(8):407-12.

PMID:
17849025
10.
11.

Drugs and other product choices.

Hyman PM, Carvajal R.

Dermatol Ther. 2009 May-Jun;22(3):216-24. doi: 10.1111/j.1529-8019.2009.01234.x. Review.

PMID:
19453345
12.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138
13.

'Off-label' drug use: an FDA regulatory term, not a negative implication of its medical use.

Meadows WA, Hollowell BD.

Int J Impot Res. 2008 Mar-Apr;20(2):135-44. Epub 2007 Nov 15. Review.

PMID:
18004389
14.

FDA recognition of consensus standards in the premarket notification program.

Marlowe DE, Phillips PJ.

Biomed Instrum Technol. 1998 May-Jun;32(3):301-4.

PMID:
9619259
15.

US definitions, current use, and FDA stance on use of platelet-rich plasma in sports medicine.

Beitzel K, Allen D, Apostolakos J, Russell RP, McCarthy MB, Gallo GJ, Cote MP, Mazzocca AD.

J Knee Surg. 2015 Feb;28(1):29-34. doi: 10.1055/s-0034-1390030. Epub 2014 Sep 30.

PMID:
25268794
16.

NCCN Oncology Risk Evaluation and Mitigation Strategies White Paper: Recommendations for Stakeholders.

Johnson PE, Dahlman G, Eng K, Garg R, Gottlieb S, Hoffman JM, Howell P, Jahanzeb M, Johnson S, Mackler E, Rubino M, Sarokhan B, Marc Stewart F, Tyler T, Vose JM, Weinstein S, Li EC, Demartino J; NCCN Oncology Risk Evaluation and Mitigation Strategies (REMS) Work Group.

J Natl Compr Canc Netw. 2010 Sep;8 Suppl 7:S7-S27.

PMID:
20947724
17.

Regulatory initiatives for natural latex allergy: US perspectives.

Farnham JJ, Tomazic-Jezic VJ, Stratmeyer ME.

Methods. 2002 May;27(1):87-92. Review.

PMID:
12079422
18.
20.

The US Food and drug administration: drug information resource for formulary recommendations.

Marchand HC, Ros BJ, Fine AM, Kremzner ME.

J Manag Care Pharm. 2012 Nov-Dec;18(9):713-8.

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