Structured frameworks for benefit‐risk analysis in drug licensing decisions are being implemented
across a number of regulatory agencies worldwide. The aim of these frameworks is to …

Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare
resources have resulted in the implementation of health technology assessment (HTA) to inform …

Objectives To evaluate the national regulatory, health technology assessment (HTA), and
reimbursement pathways for public health care in Australia, Canada, England, and Scotland, …

The variation in panaxoside content of roots and commercial products of Panax ginseng and
P. quinquefolium was evaluated by a new spectrodensitometric TLC method. The method is …

Objectives To evaluate the current practice of companies and agencies to assess the changes
made in aligning regulatory and health technology assessment (HTA) stakeholders; to …

… Giaquinto, Alberto Grignolo, Lawrence Liberti, John CW Lim, Tomas Salmonson,
Fernand Sauer, Henrietta Ukwu … Giaquinto, Alberto Grignolo, Lawrence Liberti, John CW …

Background: Health technology assessment (HTA) has increased in importance in supporting
payer decision making by assessing the relative effectiveness and cost effectiveness of …

The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs):
Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated …

There is a growing interest in aligning accelerated regulatory pathways with flexible access
and reimbursement pathways to expedite the equitable availability of high‐quality, safe, and …

A universal framework for the evaluation of the benefit-risk assessment of medicines during
development by pharmaceutical companies and in the regulatory review by regulatory …