148 related articles for article (PubMed ID: 29140657)
1. Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes.
Milner JG
Food Drug Law J; 2017; 72(1):141-88. PubMed ID: 29140657
[TBL] [Abstract][Full Text] [Related]
2. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies.
Miller JE; Wilenzick M; Ritcey N; Ross JS; Mello MM
BMJ Open; 2017 Dec; 7(12):e017917. PubMed ID: 29208616
[TBL] [Abstract][Full Text] [Related]
3. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
Rossen BR
Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
[TBL] [Abstract][Full Text] [Related]
4. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012.
Miller JE; Korn D; Ross JS
BMJ Open; 2015 Nov; 5(11):e009758. PubMed ID: 26563214
[TBL] [Abstract][Full Text] [Related]
5. Predictable materiality: a need for common criteria governing the disclosure of clinical trial results by publicly-traded pharmaceutical companies.
Cohen K; Cormier JW; Davar MV
J Contemp Health Law Policy; 2013; 29(2):201-32. PubMed ID: 23837261
[No 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. Should preemption apply in a pharmaceutical context? An analysis of the preemption debate and what regulatory compliance statutes contribute to the discussion.
Surprenant JA
Fordham Law Rev; 2008 Oct; 77(1):327-63. PubMed ID: 18982554
[TBL] [Abstract][Full Text] [Related]
8. Buckman extended: federal preemption of state fraud-on-the-FDA statutes.
Gaddis CA
Food Drug Law J; 2014; 69(1):113-36, iii. PubMed ID: 24772688
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States.
Lassman SM; Shopshear OM; Jazic I; Ulrich J; Francer J
BMJ Open; 2017 Sep; 7(9):e015110. PubMed ID: 28942418
[TBL] [Abstract][Full Text] [Related]
11. FDA reform in Congress: FDA's concerns. Food and Drug Administration.
James JS
AIDS Treat News; 1996 Apr; (no 245):5-7. PubMed ID: 11363624
[TBL] [Abstract][Full Text] [Related]
12. Promoting, improving and accelerating the drug development and approval processes.
Graul AI
Drug News Perspect; 2009; 22(1):30-8. PubMed ID: 19209297
[TBL] [Abstract][Full Text] [Related]
13. Pro-free enterprise group challenges FDA's authority to regulate drug companies' speech.
Skolnick AA
JAMA; 1994 Feb; 271(5):332, 335. PubMed ID: 8283568
[No Abstract] [Full Text] [Related]
14. Sources of regulatory information for pharmacists.
Goldwire MA; Rumore MM
Am J Hosp Pharm; 1993 Jun; 50(6):1175-81. PubMed ID: 8517457
[TBL] [Abstract][Full Text] [Related]
15. Zohydro approval by food and drug administration: controversial or frightening?
Manchikanti L; Atluri S; Candido KD; Boswell MV; Simopoulos TT; Grider JS; Falco FJ; Hirsch JA
Pain Physician; 2014; 17(4):E437-50. PubMed ID: 25054396
[TBL] [Abstract][Full Text] [Related]
16. Your business in court and at federal agencies: 2010 - 2011.
Reiss JB; Crowder D; Simons B; Pleskov I; Davis T; Nugent P
Food Drug Law J; 2012; 67(2):243-92, iii. PubMed ID: 24620420
[TBL] [Abstract][Full Text] [Related]
17. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.
Kesselheim AS; Mello MM
Health Aff (Millwood); 2007; 26(2):483-91. PubMed ID: 17339677
[TBL] [Abstract][Full Text] [Related]
18. The US Opioid Crisis: Current Federal and State Legal Issues.
Soelberg CD; Brown RE; Du Vivier D; Meyer JE; Ramachandran BK
Anesth Analg; 2017 Nov; 125(5):1675-1681. PubMed ID: 29049113
[TBL] [Abstract][Full Text] [Related]
19. Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors.
Hirsch L
Curr Med Res Opin; 2008 Jun; 24(6):1683-9. PubMed ID: 18462565
[TBL] [Abstract][Full Text] [Related]
20. Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants.
Chahal HS; Mukherjee S; Sigelman DW; Temple R
JAMA Intern Med; 2021 Apr; 181(4):522-529. PubMed ID: 33587091
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
