580 related articles for article (PubMed ID: 31407412)
1. Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.
Herder M
Milbank Q; 2019 Sep; 97(3):820-857. PubMed ID: 31407412
[TBL] [Abstract][Full Text] [Related]
2. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. The FDA and drug safety: a proposal for sweeping changes.
Furberg CD; Levin AA; Gross PA; Shapiro RS; Strom BL
Arch Intern Med; 2006 Oct; 166(18):1938-42. PubMed ID: 17030825
[TBL] [Abstract][Full Text] [Related]
5. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.
Evans BJ
Am J Law Med; 2012; 38(4):577-606. PubMed ID: 23356097
[TBL] [Abstract][Full Text] [Related]
6. US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies.
Gendy JM; Nomura N; Stuart JN; Blumenthal G
Ther Innov Regul Sci; 2024 Mar; 58(2):380-386. PubMed ID: 38182940
[TBL] [Abstract][Full Text] [Related]
7. FDA's Unimproved Enforcement of Postmarketing Requirements and Commitments: Implications for Providers and Patients.
Dauner DG; Dauner KN; Peterson ALH
Res Social Adm Pharm; 2020 Jun; 16(6):844-847. PubMed ID: 31812502
[TBL] [Abstract][Full Text] [Related]
8. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.
Moneer O; Brown BL; Avorn J; Darrow JJ; Mitra-Majumdar M; Joyce KW; Ross M; Pham C; Kesselheim AS
Drug Saf; 2022 Apr; 45(4):305-318. PubMed ID: 35182362
[TBL] [Abstract][Full Text] [Related]
9. A descriptive analysis of postmarketing requirement studies and clinical trials.
Choi L; Etchey B; Billings M; Lee C; Weil KM; Boxwell D; Edelberg H
Pharmacoepidemiol Drug Saf; 2024 Jan; 33(1):e5725. PubMed ID: 37994284
[TBL] [Abstract][Full Text] [Related]
10. Extending the US Food and Drug Administration's Postmarket Authorities.
Fernandez Lynch H; Sachs RE; Lee S; Herder M; Ross JS; Ramachandran R
JAMA Health Forum; 2023 Jun; 4(6):e231313. PubMed ID: 37294583
[TBL] [Abstract][Full Text] [Related]
11. What Commissioner Gottlieb's FDA Is Doing to Lower Prescription Drug Prices and Steps Congress Can Take to Help.
Waxman H; Corr B; Martin K; Duong S
Issue Brief (Commonw Fund); 2018 Apr; 2018():1-10. PubMed ID: 29992802
[TBL] [Abstract][Full Text] [Related]
12. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.
Nguyen D; Seoane-Vazquez E; Rodriguez-Monguio R; Montagne M
BMC Health Serv Res; 2013 Jan; 13():27. PubMed ID: 23339419
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments.
Skydel JJ; Luxkaranayagam AT; Dhruva SS; Ross JS; Wallach JD
JAMA Netw Open; 2019 May; 2(5):e193410. PubMed ID: 31074812
[TBL] [Abstract][Full Text] [Related]
15. 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]
16. Off-label use of medical devices in radiology: regulatory standards and recent developments.
Smith JJ
J Am Coll Radiol; 2010; 7(2):115-9. PubMed ID: 20142085
[TBL] [Abstract][Full Text] [Related]
17. 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; 18(9):713-8. PubMed ID: 23206214
[TBL] [Abstract][Full Text] [Related]
18. Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis.
Wallach JD; Luxkaranayagam AT; Dhruva SS; Miller JE; Ross JS
BMC Med; 2019 Jun; 17(1):117. PubMed ID: 31203816
[TBL] [Abstract][Full Text] [Related]
19. Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval.
Neumann PJ; Crummer E; Chambers JD; Tunis SR
Milbank Q; 2023 Dec; 101(4):1047-1075. PubMed ID: 37644739
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]