1174 related articles for article (PubMed ID: 19095852)
1. The new Food and Drug Administration drug package insert: implications for patient safety and clinical care.
Watson KT; Barash PG
Anesth Analg; 2009 Jan; 108(1):211-8. PubMed ID: 19095852
[TBL] [Abstract][Full Text] [Related]
2. The history and contemporary challenges of the US Food and Drug Administration.
Borchers AT; Hagie F; Keen CL; Gershwin ME
Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
[TBL] [Abstract][Full Text] [Related]
3. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.
Basile EM; Tolomeo D; Gluck E
Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744
[TBL] [Abstract][Full Text] [Related]
4. Patient package inserts: the proper prescription?
Rowe HM
Food Drug Law J; 1995; 50(1):95-124. PubMed ID: 10342988
[No Abstract] [Full Text] [Related]
5. Prescription drug products; patient package insert requirements--Food and Drug Administration. Final rule.
Fed Regist; 1981 Jan; 46(1):28-30. PubMed ID: 10324121
[TBL] [Abstract][Full Text] [Related]
6. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.
Roller ST; Pippins RR; Ngai JW
Food Drug Law J; 2009; 64(3):577-98. PubMed ID: 19999646
[TBL] [Abstract][Full Text] [Related]
7. The FDA announces new prescription drug information format.
FDA Consum; 2006; 40(2):25-7. PubMed ID: 16671197
[TBL] [Abstract][Full Text] [Related]
8. 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. PubMed ID: 18618967
[No Abstract] [Full Text] [Related]
9. Vioxx's history and the need for better procedures and better testing.
Gilhooley M
Seton Hall Law Rev; 2007; 37(4):941-68. PubMed ID: 18363218
[No Abstract] [Full Text] [Related]
10. FDA regulatory compliance reconsidered.
Tobias C
Cornell Law Rev; 2008 Jul; 93(5):1003-38. PubMed ID: 18618969
[No Abstract] [Full Text] [Related]
11. Requirements on content and format of labeling for human prescription drug and biological products. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2006 Jan; 71(15):3921-97. PubMed ID: 16479698
[TBL] [Abstract][Full Text] [Related]
12. History of FDA patient package insert requirements.
Am J Hosp Pharm; 1980 Dec; 37(12):1660-1. PubMed ID: 7004180
[No Abstract] [Full Text] [Related]
13. An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.
Knoben JE; Scott GR; Tonelli RJ
Am J Hosp Pharm; 1990 Dec; 47(12):2696-700. PubMed ID: 2278285
[TBL] [Abstract][Full Text] [Related]
14. Antiperspirant drug products for over-the-counter human use; final monograph. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2003 Jun; 68(110):34273-93. PubMed ID: 12795305
[TBL] [Abstract][Full Text] [Related]
15. 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. PubMed ID: 19101138
[TBL] [Abstract][Full Text] [Related]
16. Status of certain additional over-the-counter drug category II and III active ingredients. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2002 May; 67(90):31123-5. PubMed ID: 12001971
[TBL] [Abstract][Full Text] [Related]
17. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
Harapanhalli RS
Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
[TBL] [Abstract][Full Text] [Related]
18. Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule.
Food and Drug Administration, HHS
Fed Regist; 2003 Jun; 68(114):35290-3. PubMed ID: 12807133
[TBL] [Abstract][Full Text] [Related]
19. The First Amendment and FDA restrictions on off-label uses: the call for a new approach.
Leghorn J; Brophy E; Rother P
Food Drug Law J; 2008; 63(2):391-406. PubMed ID: 18561466
[No Abstract] [Full Text] [Related]
20. Cloned animal products in the human food chain: FDA should protect American consumers.
Butler JE
Food Drug Law J; 2009; 64(3):473-501. PubMed ID: 19999640
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
