United States FDA Introduces a New Initiative Readers may be familiar with the words of FDAs Janet Woodcock, MD, in the early 2000s, calling for: “A maximally efficient, agile, flexible…
In Part 1, we concluded that 21st Century cGMP faces critical challenges, given four-decades of strategic realignment of industry business models. Readers wishing to recap can find Part 1 here.…
What is cGMP for the 21st Century? As many reading this will know, cGMP, stands for current Good Manufacturing Practice. It is the quality management system (QMS) FDA mandates for…
What is medicinal product (drug) repurposing? Repurposing a medicinal product (drug or biologic) involves gaining a licence for an already approved, non-patented product, in different indications from that already approved. …
Bridgend, South Wales, 7th June 2022: PharmaFlow, a 21st century consultancy in biopharmaceutical value-chains, is pleased to announce that founder and managing director, Hedley Rees, has published his latest book…
Bridgend, South Wales, 29th March 2021: Following the chaos and confusion during COVID-19, Hedley Rees has decided to share his deep experience of pharmaceutical production and distribution supply chains, including…
Who would argue that we don't need innovation in biopharmaceuticals? Some are even calling for disruptive innovation, to tackle the thorny issues of affordability and availability of new medical products.…
The answer is 'far less than you would think!' In this STAT article Letting academic medical centers make CAR-T drugs would save billions, medical centres in the US, and their…