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Items: 1 to 20 of 99

1.

Response to the letter by Mol.

Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, Shoaibi A, Gurwitz JH.

Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):106. doi: 10.1002/pds.3519. No abstract available.

PMID:
24395548
2.

Critically reviewing impact of regulatory actions, not just FDA's.

Mol PG.

Pharmacoepidemiol Drug Saf. 2014 Jan;23(1):105. doi: 10.1002/pds.3509. No abstract available.

PMID:
24395547
3.

The federal preemption debate in pharmaceutical labeling product liability actions.

Gross JM, Curry JA.

Tort Trial Insur Pract Law J. 2007 Fall;43(1):35-70. No abstract available.

PMID:
18354866
4.

Flight 483 now boarding.

Czap A.

Altern Med Rev. 2010 Sep;15(3):183-5. No abstract available.

5.

A critical review of methods to evaluate the impact of FDA regulatory actions.

Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, Shoaibi A, Gurwitz JH.

Pharmacoepidemiol Drug Saf. 2013 Sep;22(9):986-94. doi: 10.1002/pds.3480. Epub 2013 Jul 12. Review.

6.

Premarket notifications of new dietary ingredients--a ten-year review.

McGuffin M, Young AL.

Food Drug Law J. 2004;59(2):229-44. No abstract available.

PMID:
15318394
7.

The Supreme Court, preemption, and malpractice liability.

Kesselheim AS, Studdert DM.

N Engl J Med. 2009 Feb 5;360(6):559-61. doi: 10.1056/NEJMp0809403. No abstract available.

8.

Regulators need to regulate. For health and safety issues, the nation needs watchdogs to be on guard.

May D.

Mod Healthc. 2010 Mar 1;40(9):16. No abstract available.

PMID:
20344831
9.

The issue of extralabel drug use.

Kennedy JA.

J Am Vet Med Assoc. 1997 Dec 1;211(11):1354. No abstract available.

PMID:
9394877
10.

APhA2009 House of Delegates: serving the association and the profession.

Weitzel KW, Tisdale JE, Mattingly J.

J Am Pharm Assoc (2003). 2009 Jul-Aug;49(4):474-80. doi: 10.1331/JAPhA.2009.09520. No abstract available.

PMID:
19589755
11.

The case for preemption of prescription drug failure-to-warn claims.

Kim CH.

Food Drug Law J. 2007;62(2):399-422. No abstract available.

PMID:
17632969
12.

Assessing supplement safety--the FDA's controversial proposal.

Cohen PA.

N Engl J Med. 2012 Feb 2;366(5):389-91. doi: 10.1056/NEJMp1113325. Epub 2012 Jan 25. No abstract available.

13.

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
14.

Off-label uses of drugs and medical devices: should the FDA crack down?

Margolis RE.

Healthspan. 1993 Jan;10(1):18-9. No abstract available.

PMID:
10124289
15.

Pin the tail on the other donkey: allocating and avoiding injury losses after drug or device approval.

O'Reilly JT.

Food Drug Law J. 2007;62(3):559-72. No abstract available.

PMID:
17915397
16.

Drug review "behind the curtain": a response to Professor Struve.

O'Reilly JT.

Cornell Law Rev. 2008 Jul;93(5):1075-90. No abstract available.

PMID:
18618971
17.

Is it a cosmetic, a drug, or both? (Or is it soap?).

Center for Safety and Applied Nutrition/Office of Cosmetics and Colors US Food and Drug Administration.

Plast Surg Nurs. 2008 Oct-Dec;28(4):195-7. doi: 10.1097/01.PSN.0000342824.90128.fd. No abstract available.

PMID:
19092587
18.

FDA prohibits extralabel use of two drug classes.

[No authors listed]

J Am Vet Med Assoc. 1997 Aug 1;211(3):269. No abstract available.

PMID:
9262656
19.

Homoeopathic product licence. MHRA label seems to be illegal.

Colquhoun D.

BMJ. 2009 Jun 9;338:b2333. doi: 10.1136/bmj.b2333. No abstract available.

PMID:
19509427
20.

The Food and Drug Administration's paternalism.

Somberg JC.

Am J Ther. 2010 Nov-Dec;17(6):533-4. doi: 10.1097/MJT.0b013e3182027b95. No abstract available.

PMID:
21060255

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