European Pharmaceutical Review

JANUARY 2, 2024

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. It also lowers the regulatory burden too, the paper reported. [In The team examined the European Public Assessment Report (EPAR) for the QbD approach.

Drug Development 105

Drug Development Biosimilars Documentation 105

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

Drug Development 52

Drug Development Documentation Communication 52

pharmaphorum

OCTOBER 29, 2020

In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early scientific advice, at a cost. Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA).

Documentation 101

Documentation Drug Development 101