Drug review process advancement and required manufacturer and contract research oraganization responses
J Toxicol Pathol. 2024 Apr;37(2):45-53. doi: 10.1293/tox.2023-0106. Epub 2023 Nov 22.ABSTRACTThe United States Senate passed the "FDA Modernization Act 2.0." on September 29, 2022. Although the effectiveness of this Bill, which aims to eliminate the mandatory use of laboratory animals in new drug development, is limited, it represents a significant trend that will change the shape of drug applications in the United States and other countries. However, pharmaceutical companies have not taken major steps towards the complete elimination of animal testing from the standpoint of product safety, where they prioritize patient sa...
Source: Journal of Toxicologic Pathology - April 8, 2024 Category: Toxicology Authors: Takayuki Anzai Glenn J Myatt Frances Hall Brenda Finney Kenshi Nakagawa Hijiri Iwata Reo Anzai Anne Dickinson Matthew Freer Dai Nakae Hiroshi Onodera Takaaki Matsuyama Source Type: research

A Sponsor ’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
ConclusionsThe reexamination process did not result in regulatory changes for any of the examined drugs. The Japan new-drug application (J-NDA) review and approval process, including implementation of the initial Japan product label, assures acceptable benefit/risk at the time of approval such that mandatory GDUI or SI studies for all products should be reconsidered. In the case of genuine scientific uncertainty to the extent that the benefit/risk of the product is not clear, a PMS is warranted. (Source: Pharmaceutical Medicine)
Source: Pharmaceutical Medicine - March 31, 2024 Category: Drugs & Pharmacology Source Type: research

Requesting conflicts of interest declarations from the European Medicines Agency: 3-year follow-up status
CONCLUSIONS: After almost 3 years, we received information, which only partly addressed our request. We recommend EMA to improve transparency by publishing the author names and their corresponding conflicts of interest declarations directly in the 'Clinical efficacy and safety' guidelines and to not remove conflicts of interest declarations after 1 year from their website to reduce the risk of stealth corporate influence during the development of these influential guidelines.PMID:38529624 | DOI:10.1017/S2045796024000179 (Source: Epidemiology and Psychiatric Sciences)
Source: Epidemiology and Psychiatric Sciences - March 26, 2024 Category: Psychiatry Authors: K Boesen P C G øtzsche J P A Ioannidis Source Type: research

Critical Comments by FDA Reviewers on Patient-Reported Outcomes in FDA Regulatory Submissions (2018-2021)
This manuscript examines the inclusion of patient-reported outcome (PRO) data in new drug applications (NDAs) submitted to the Food and Drug Administration (FDA) and approved from 2018 through 2021. The importance of assessing PROs, which capture patients ’ perspectives on the disease and treatment experience, has been underscored by many stakeholders, including regulatory authorities. Despite the increasing inclusion of PRO assessments in registration trials, inclusion of language related to PRO results in approved product labeling varies widely. (Source: Value in Health)
Source: Value in Health - March 6, 2024 Category: International Medicine & Public Health Authors: Christina Slota, Lindsey Norcross, Erin Comerford, Medha Sasane, Ying Zheng, Ari Gnanasakthy Source Type: research

Critical Comments by Food and Drug Administration Reviewers on Patient-Reported Outcomes in Food and Drug Administration Regulatory Submissions (2018-2021)
This article examined the inclusion of patient-reported outcome (PRO) data in new drug applications (NDAs) submitted to the Food and Drug Administration (FDA) and approved from 2018 to 2021. The importance of assessing PROs, which capture patients ’ perspectives on the disease and treatment experience, has been underscored by many stakeholders, including regulatory authorities. Despite the increasing inclusion of PRO assessments in registration trials, inclusion of language related to PRO results in approved product labeling varies widely. (Source: Value in Health)
Source: Value in Health - March 6, 2024 Category: International Medicine & Public Health Authors: Christina Slota, Lindsey Norcross, Erin Comerford, Medha Sasane, Ying Zheng, Ari Gnanasakthy Tags: Patient-Reported Outcomes Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research

Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research