Regulatory Review Commission + Regulatory Budget = a Diet for Better, More Effective Regulations

2019 ◽  
Author(s):  
Patrick A. McLaughlin ◽  
Tyler Richards
Keyword(s):  
Regulatory Review ◽  
Regulatory Budget

Office of Information and Regulatory Affairs: Past, Present, and Future

2019 ◽  
Vol 11 (1) ◽  
pp. 2-37 ◽  
Author(s):  
Jim Tozzi
Keyword(s):  
Final Section ◽  
Critical Role ◽  
Executive Order ◽  
Review System ◽  
Regulatory Review ◽  
Executive Orders ◽  
Regulatory Affairs ◽  
Final Rule ◽  
Regulatory Budget

AbstractThis article has three sections, each of which deals with an Executive Order. The first section, “Office of Information and Regulatory Affairs (OIRA) Past,” emphasizes the critical role that Executive Orders played in the formation of OIRA. More specifically, OIRA owes its initial existence to the establishment of a centralized regulatory review system, the Quality of Life Review, which initiated Office of Management and Budget (OMB) review of environmental regulations through the issuance of a directive from OMB. Every subsequent President expanded OMBs powers through the issuance of Executive Orders which culminated in the Iconic Executive Order 12291. The section concludes with the recommendation that a select class of Executive Orders, and OMB Directives, be designated as “Iconic” by the National Archivist in consultation with the OIRA, and then given substantial deference by incoming Administrations. The second section, “OIRA Present,” describes an Executive Order issued during the Kennedy Administration which remains in effect but was promulgated prior to the establishment of OIRA and therefore recommends that a new Executive Order be issued which gives OIRA specific authority to participate in the conduct of interagency reviews of Executive Orders. The third section, “OIRA Future,” describes an Executive Order which implements a regulatory budget (RB) and institutionalizes a mechanism for controlling the size of the administrative state. This final section of the article recommends that the aforementioned Executive Order be reviewed and modified based upon the outcome of a request for public comments, and rules with demonstrated positive net benefits should no longer be accorded an automatic entitlement for issuance as a final rule absent their inclusion in an RB.

2019 Investment Policy and Regulatory Review - Nigeria

10.1596/33596 ◽  
2020 ◽  
Author(s):  
Keyword(s):  
Investment Policy ◽  
Regulatory Review

Tender Offer Merger and Regulatory Review in Spanish Law (in Spanish)

2008 ◽  
Author(s):  
Francisco Marcos
Keyword(s):  
Regulatory Review ◽  
Tender Offer ◽  
Spanish Law

Promise and Peril: Implementing a Regulatory Budget

1996 ◽  
Author(s):  
Clyde Wayne Crews Jr.
Keyword(s):  
Regulatory Budget

Rationales of delay and difference in regulatory review by Japan, the United States, and Europe among new drugs first approved in Japan

2021 ◽  
Author(s):  
Mototsugu Tanaka ◽  
Mayumi Idei ◽  
Hiroshi Sakaguchi ◽  
Ryosuke Kato ◽  
Daisuke Sato ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review

The challenges from regulatory review and assessment of experimental power reactor site in Indonesia

2021 ◽  
Author(s):  
I. T. Rusmanatmojo ◽  
B. Rohman ◽  
R. E. Harianto ◽  
A. Awalludin
Keyword(s):  
Power Reactor ◽  
Regulatory Review

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies

2019 ◽  
Vol 143 (1) ◽  
pp. 73-77
Author(s):  
Anat Gafter-Gvili ◽  
Ariadna Tibau ◽  
Pia Raanani ◽  
Daniel Shepshelovich
Keyword(s):  
Hematological Malignancies ◽  
New Drugs ◽  
Priority Review ◽  
Regulatory Review ◽  
Regulatory Pathways ◽  
The Us ◽  
Black Box Warnings ◽  
Accelerated Approval ◽  
Drug Approvals ◽  
Approved Drugs

The prevalence of safety-related postmarketing label modifications of medications for hematological malignancies is unknown. We identified 35 new drugs indicated for hematological malignancies approved by the US Food and Drug Administration between January 1999 and December 2014. Characteristics of supporting trials and safety-related label modifications from approval to December 2017 were collected from drug labels. Regulatory review and approval pathways were also collected. New drug approvals were supported by trials with a median of 167 patients (interquartile range 115–316). All drugs were approved based on surrogate endpoints. Twenty-seven drug approvals (77%) were not supported by randomized controlled trials. All drugs received orphan drug designation, and most were granted fast track designation, priority review, and accelerated approval (83, 74, and 60%, respectively). A total of 28 drugs (80%) had postmarketing safety-related label modifications. Additions to black box warnings, contraindications, warnings and precautions, and common adverse reactions were identified in 31, 11, 77, and 46% of drugs, respectively. Five drugs (14%) were permanently or temporarily withdrawn from the US market. Drugs for hematological malignancies are often approved based on limited evidence through expedited regulatory pathways with incomplete safety profiles. Hematologists should be vigilant for unrecognized side effects when prescribing newly approved drugs.

scholarly journals Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria

2019 ◽  
Vol 10 ◽  
pp. 204062071987472 ◽  
Author(s):  
Robert M. Stern ◽  
Nathan T. Connell
Keyword(s):  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Bone Marrow Failure ◽  
Phase Iii ◽  
The European Union ◽  
Regulatory Review ◽  
Dosing Schedule ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Us Fda

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare stem cell disorder characterized by hemolytic anemia, bone marrow failure, and thrombosis. Until recently, the complement inhibitor, eculizumab, was the only United States Food and Drug Administration (US FDA)-approved therapy for the treatment of PNH. Although effective, eculizumab requires a frequent dosing schedule that can be burdensome for some patients and increases the risk of breakthrough intravascular hemolysis. Ravulizumab, an eculizumab-like monoclonal antibody engineered to have a longer half-life, is intended to provide the same benefits as eculizumab but with a more convenient and effective dosing schedule. In two recently published phase III non-inferiority trials, ravulizumab was found to be non-inferior to eculizumab both in efficacy and safety for the treatment of patients with PNH. Based on these results, ravulizumab was approved by the US FDA on 21 December 2018 and is currently under regulatory review in both the European Union and Japan.

Toward a Regulatory Budget

1997 ◽  
Vol 17 (1) ◽  
pp. 89-98 ◽  
Author(s):  
Fred Thompson
Keyword(s):  
Regulatory Budget
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