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. …
Dear Ms. Cooke, This is an open letter in relation to a question I submitted via EMAs: Send a question to the European Medicines Agency, on 20/12/2020. This is EMAs…
Dear Dr Califf, This is an open letter in follow-up to a question I have submitted to the FDA’s Center for Biologics Evaluation and Research (CBER). The question is repeated…
Bridgend, South Wales, 6th June 2024: Hedley Rees, managing director at PharmaFlow, a 21st century consultancy in biopharmaceutical value chain management, calls for MHRA to investigate if AstraZeneca must instigate…
Who would argue that we innovation in the pharmaceutical industry? Of course you would! Some are even calling for disruptive innovation, to tackle the thorny issues of affordability, availability, and…
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…