Top 2021 Insights from Global Regulators
Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for…
Tagged with FDA
Saudi Arabia: Significant Steps Towards Clinical Trial Hub Status
Clinical trials provide a pathway to innovation for clinicians and patients in countries like Saudi Arabia and form a key element of the country’s…
USA: Importance of the Patient Voice in Drug Development:…
Writing in the May edition of DIA’s Global Forum magazine, Erica Lyons, Sarrit Kovacs, Matthew Kowalik, and Jessica Lee from the Division of…
Saudi Arabia: SFDA CEO Sets Out Strategic Priorities
In a recent conversation with PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) outlined the…
Hisham Bin Saad Al-Jadhey – CEO, Saudi Food and Drug…
Speaking exclusively to PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA), outlines the SFDA's key…
US FDA Drug Approvals 2020
In 2020, the US FDA's Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic…
What to Expect if Janet Woodcock Becomes Permanent FDA Head
Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs…
The Long Read: Innovation, Access & Affordability in the USA
A Tale of Two Americas The US stands as the biopharma innovation champion of the world, a global leader on nearly all R&D indices related to…
Top 10 PharmaBoardroom Interviews of 2020
2020 was a challenging year globally, but one in which the importance of the healthcare and life sciences sector was underlined like never before.…
Rare Disease Strategies in the Booming US Market
Rare disease – defined in the US as a disease with a maximum patient population of 200,000 – is perhaps the most salient issue at the nexus of…
Aducanumab edges closer to Potential Approval: Next up, the…
In his latest piece on Alzheimer’s Disease (AD) drug Aducanumab’s winding journey to market, Dr Neil Cashman looks forward to the US FDA Advisory…
Peter Marks – Director, Center for Biologics Evaluation and…
Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights…
