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Items: 1 to 20 of 415

1.

Shifting terrain in the regulation of off-label promotion of pharmaceuticals.

Mello MM, Studdert DM, Brennan TA.

N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695. No abstract available.

PMID:
19357413
2.

Teaching clinicians about drugs--50 years later, whose job is it?

Avorn J.

N Engl J Med. 2011 Mar 31;364(13):1185-7. doi: 10.1056/NEJMp1011713. No abstract available.

3.

Marketing off-label uses to physicians: FDA's draft (mis)guidance.

Gass A, Wilson J.

Am J Bioeth. 2008 Mar;8(3):1-3. doi: 10.1080/15265160802116624. No abstract available.

4.

Vioxx's history and the need for better procedures and better testing.

Gilhooley M.

Seton Hall Law Rev. 2007;37(4):941-68. No abstract available.

PMID:
18363218
5.

Pros and cons of off-label promotion investigations and prosecutions.

Loucks MK.

Food Drug Law J. 2006;61(3):577-83. No abstract available.

PMID:
16989041
6.

Off-label or off-limits?

Ratner M, Gura T.

Nat Biotechnol. 2008 Aug;26(8):867-75. doi: 10.1038/nbt0808-867. No abstract available.

PMID:
18688236
7.

The FDA and deference lost: a self-inflicted wound or the product of a wounded agency? A response to Professor O'Reilly.

Vladeck DC.

Cornell Law Rev. 2008 Jul;93(5):981-1002. No abstract available.

PMID:
18618967
8.

Pharmacometrics at FDA: evolution and impact on decisions.

Powell JR, Gobburu JV.

Clin Pharmacol Ther. 2007 Jul;82(1):97-102. Epub 2007 May 30. Review.

PMID:
17538553
9.
10.

Access before approval--a right to take experimental drugs?

Okie S.

N Engl J Med. 2006 Aug 3;355(5):437-40. No abstract available.

11.

Regulatory experts debate FDA's authority.

Young D.

Am J Health Syst Pharm. 2007 May 1;64(9):910, 912. No abstract available.

PMID:
17468140
12.

Pharmaceuticals and medical devices: FDA oversight. Issue brief.

Thomson Reuters/West.

Issue Brief Health Policy Track Serv. 2011 Jan 3:1-39. No abstract available.

PMID:
21374841
13.

The Neurontin legacy--marketing through misinformation and manipulation.

Landefeld CS, Steinman MA.

N Engl J Med. 2009 Jan 8;360(2):103-6. doi: 10.1056/NEJMp0808659. No abstract available.

PMID:
19129523
14.

Forbidden and Permitted Statements about Medications--Loosening the Rules.

Avorn J, Sarpatwari A, Kesselheim AS.

N Engl J Med. 2015 Sep 3;373(10):967-73. doi: 10.1056/NEJMhle1506365. No abstract available.

PMID:
26332553
15.

Shattuck lecture. Innovation, regulation, and the FDA.

Hamburg MA.

N Engl J Med. 2010 Dec 2;363(23):2228-32. doi: 10.1056/NEJMsa1007467. No abstract available.

16.
17.

Pharmaceutical promotion and First Amendment rights.

Troy DE, Gottlieb S.

N Engl J Med. 2008 Jul 31;359(5):536; author reply 536-7. doi: 10.1056/NEJMc081122. No abstract available.

18.

Practical, legal, and ethical issues in expanded access to investigational drugs.

Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS.

N Engl J Med. 2015 Jan 15;372(3):279-86. doi: 10.1056/NEJMhle1409465. No abstract available.

19.

Pharmaceutical promotion to physicians and First Amendment rights.

Kesselheim AS, Avorn J.

N Engl J Med. 2008 Apr 17;358(16):1727-32. doi: 10.1056/NEJMsb0708920. No abstract available.

PMID:
18420505
20.

The Vernacular of Risk--Rethinking Direct-to-Consumer Advertising of Pharmaceuticals.

Greene JA, Watkins ES.

N Engl J Med. 2015 Sep 17;373(12):1087-9. doi: 10.1056/NEJMp1507924. Epub 2015 Aug 19. No abstract available.

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