Improving regulatory efficiency for biotechnology products

Improving regulatory efficiency for biotechnology products

Small procedural changes in how regulatory agencies implement biotech policies can make significant differences in improving regulatory efficiency. This paper discusses how science based, crop specific guidance documents can improve dossier content and the review and approval of biotech varieties. I...

Full description

Bibliographic Details
Main Authors:	Muffy Koch, Matthew G. Pence, Jaylee DeMond, Gary Rudgers
Format:	Article
Language:	English
Published:	Frontiers Media S.A. 2024-01-01
Series:	Frontiers in Bioengineering and Biotechnology
Subjects:	regulation risk assessment decision making data requirements regulatory efficiency
Online Access:	https://www.frontiersin.org/articles/10.3389/fbioe.2024.1354743/full

Similar Items

Applying knowledge and experience from potato (Solanum tuberosum) to update genetic stability data requirements in the risk assessment for vegetatively propagated biotech crops
by: Matthew G. Pence, et al.
Published: (2024-04-01)

Regulatory impact assessment and “regulatory guillotine” as institutional forms of business community’s participation in the improvement of regulatory framework in Russia
by: A. A. Lialikov
Published: (2022-09-01)

Transferability of real-world data across borders for regulatory and health technology assessment decision-making
by: Ashley Jaksa, et al.
Published: (2022-11-01)

RISK AS A REGULATORY TOOL
by: Rui Vilar, et al.
Published: (2013-06-01)

A Pathway to Linking Risk and Sustainability Assessments
by: Stephen H. Linder, et al.
Published: (2014-10-01)

Do personality traits and self‐regulatory processes affect decision‐making tendencies?
by: Silvana Miceli, et al.
Published: (2018-09-01)

Regulatory focus affects physician risk tolerance
by: Peter J. Veazie, et al.
Published: (2014-09-01)

A Framework of Type-2 Neutrosophic for Requirements Prioritization
by: Basma K. Eldrandaly
Published: (2023-01-01)

Implementation of regulatory policy in economic activity: development of the institute regulatory impact assessment
by: Viktor Koval, et al.
Published: (2017-10-01)

Can Standardisation of the Public Assessment Report Improve Benefit-Risk Communication?
by: Andrea Keyter, et al.
Published: (2020-06-01)

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture
by: Jennifer Kuzma, et al.
Published: (2023-09-01)

Assessment of compliance to packaging and labeling regulatory requirements of locally manufactured alcohol-based hand sanitizers marketed in Addis Ababa, Ethiopia
by: Tesfa Marew Wallelign, et al.
Published: (2022-12-01)

Risk assessment and decision making in business and industry : a practical guide /
by: 416740 Koller, Glenn R. (Glenn Robert), 1951-
Published: (2005)

Evaluating the ability of decision-makers to estimate risks effectively in industrial applications
by: Pieterse, Werner, et al.
Published: (2014-11-01)

The Swedish version of the Regulatory Mode Questionnaire
by: Danilo Garcia, et al.
Published: (2017-10-01)

Gain +1 or Avoid −1: Validation of the German Regulatory Focus Questionnaire (RFQ)
by: Bjarne Schmalbach, et al.
Published: (2017-12-01)

Data-driven urban regeneration: university housing in the ex-Corradini factory in Naples
by: Sergio Ermolli, et al.
Published: (2022-07-01)

Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy
by: Philip A. Hines, et al.
Published: (2020-09-01)

Ethical and regulatory challenges of AI technologies in healthcare: A narrative review
by: Ciro Mennella, et al.
Published: (2024-02-01)

Accident and design : contemporary debates on risk management /
by: Hood, Christopher, 1947-, et al.
Published: (1996)

A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements
by: Giannakou C, et al.
Published: (2016-06-01)

The Impact of Regulatory Capital on Risk Taking By Pakistani Banks
by: Muhammad Sajjad Hussain, et al.
Published: (2019-03-01)

Risk-Based Regulation as a Reflexive Regulatory Strategy
by: Przemysław Brzuszczak
Published: (2020-09-01)

Quantitative risk assessment : the scientific platform /
by: Aven, T. (Terje) 225623
Published: (2011)

An anatomy of risk /
by: 360509 Rowe, William D.
Published: (1977)

Risk analysis and scientific method : methodological and ethical problems with evaluating societal hazards /
by: 176087 Shrader-Frechette, K. S.
Published: (1985)

Decision analysis for petroleum exploration /
by: 389710 Newendorp, Paul D., et al.
Published: (2000)

Risk modeling for determining value and decision making /
by: 416740 Koller, Glenn R.
Published: (2000)

Info-gap decision theory : decisions under severe uncertainty /
by: Ben-Haim, Yakov, 1952-
Published: (2006)

Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea
by: Kyung-Bok Son, et al.
Published: (2022-03-01)

Are Frontier Efficiency Methods Adequate to Compare the Efficiency of Water Utilities for Regulatory Purposes?
by: Elvira Estruch-Juan, et al.
Published: (2020-04-01)

Integrating Resilience into Risk Matrices: A Practical Approach to Risk Assessment with Empirical Analysis
by: Ali Vaezi, et al.
Published: (2023-12-01)

Grey Regulatory Focus Theory Weighting Method for the Multi-Criteria Decision-Making Problem in Evaluating University Reputation
by: Moses Olabhele Esangbedo, et al.
Published: (2019-02-01)

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan
by: Haruka Shida, et al.
Published: (2023-02-01)

Establishing a core dossier for multiple regulatory submissions: a case study in the Latin America region
by: Alva Lucia Alvarez, et al.
Published: (2023-05-01)

STGA-CBR: A Case-Based Reasoning Method Based on Spatiotemporal Trajectory Similarity Assessment
by: Zhang Keke, et al.
Published: (2020-01-01)

Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities
by: Orin Chisholm, et al.
Published: (2022-01-01)

Efficiency of implementation of the regional target program for the treatment of patients with arterial hypertension at the regional level (experience of the Vologda Oblast)
by: Georgii Germanovich Rapakov, et al.
Published: (2014-11-01)

Regulatory network operations in the Pathway Tools software
by: Paley Suzanne M, et al.
Published: (2012-09-01)

Group Decision-Making and a Design Communication Model Using Quality Function Deployment
by: Jaeyoul Chun, et al.
Published: (2018-01-01)