scholarly journals Research and the Approval Process: The Organization of Persuasion

2019 ◽  
Vol 109 (3) ◽  
pp. 911-955 ◽  
Author(s):  
Emeric Henry ◽  
Marco Ottaviani
Keyword(s):  
Information Acquisition ◽  
Drug Approval ◽  
Regulatory Process ◽  
Approval Process ◽  
Control Rights ◽  
Classic Solution ◽  
Organizational Rules ◽  
And Control ◽  
Normative Perspective

An informer sequentially collects and disseminates information through costly research to persuade an evaluator to approve an activity. Payoffs and control rights are split between informer and evaluator depending on the organizational rules governing the approval process. The welfare benchmark corresponds to Wald’s classic solution for a statistician with payoff equal to the sum of informer and evaluator. Organizations with different commitment power of informer and evaluator are compared from a positive and normative perspective. Granting authority to the informer is socially optimal when information acquisition is sufficiently costly. The analysis is applied to the regulatory process for drug approval. (JEL D82, D83, I18, L51, L65, O31)

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

2016 ◽  
Vol 4 (2) ◽  
pp. 1-9
Author(s):  
Lincy Joseph ◽  
Mathew George ◽  
Kalpesh K Malaviya ◽  
Kalpesh K Malaviya ◽  
Bincy K Chacko ◽  
...  
Keyword(s):  
Generic Drug ◽  
Drug Approval ◽  
Evaluation Agency ◽  
Approval Process ◽  
Registration Process ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Government Websites ◽  
Drug Approval Process ◽  
Regulatory Sites

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements. 

MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

2013 ◽  
Vol 1 (3) ◽  
pp. 1-6
Author(s):  
Pankaj Kashyap ◽  
Eshant Duggal ◽  
Parveen Budhwar ◽  
Jitendra Kumar Badjatya
Keyword(s):  
Generic Drug ◽  
Patent Protection ◽  
Drug Approval ◽  
Approval Process ◽  
Generic Medicines ◽  
Healthcare Provision ◽  
Pharmaceutical Markets ◽  
Global Issue ◽  
Drug Approval Process ◽  
High Level

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process. 

Venedig und der „wilde Osten“

2020 ◽  
Vol 100 (1) ◽  
pp. 208-260
Author(s):  
Christof Paulus ◽  
Albert Weber
Keyword(s):  
Middle Ages ◽  
Information Acquisition ◽  
Research Field ◽  
15Th Century ◽  
Late Middle Ages ◽  
Ranking Criteria ◽  
Areas Of Interest ◽  
And Control

AbstractVenice is considered the best-informed community of the late Middle Ages. The study examines the availability of information for the second half of the 15th century, particularly with regard to the key year 1462/1463, and as a case study concentrates on areas of the supposed Venetian periphery of interest, above all Hungary and the two principalities of Wallachia and Moldavia. The result is a thoroughly differentiated system of information acquisition, verification and control. Means of communication, as well as different areas of interest of the Serenissima, can be identified. A distinction is made between information maps and communication maps. The latter also include the distribution of news from the lagoon city exchanged with foreign envoys. During the period concerned, news was exchanged in an astonishingly liberal way, in turn integrating the Serenissima into the information networks of the other Italian states. The study thus places the „information commodity“ within the research field of late medieval gift exchange and patronage structures. In short, a thoroughly pragmatic Venetian approach to news acquisition and evaluation can be observed. Verification of the quality of the information obtained was subject not least to quantitative and ranking criteria. Ultimately, the informational power of Venice was based above all on its outstanding reputation among its contemporaries.

Acceleration of drug approval process a dangerous move

2006 ◽  
Vol &NA; (1546) ◽  
pp. 2
Author(s):  
&NA;
Keyword(s):  
Drug Approval ◽  
Approval Process ◽  
Drug Approval Process

A Proposal for Radical Changes in the Drug-Approval Process

2006 ◽  
Vol 355 (6) ◽  
pp. 618-623 ◽  
Author(s):  
Alastair J.J. Wood
Keyword(s):  
Drug Approval ◽  
Approval Process ◽  
Drug Approval Process
Sign in / Sign up

Export Citation Format

Share Document