Tagged with FDA

USA After US life expectancy fell for a second consecutive year, FDA Commissioner, Dr Robert M. Califf, speaking at the recent 2022 Biotechnology Innovation Organization (BIO22) International Convention, discussed what he believes to be the leading cause of death in the United States. Commissioner Califf stated during a fireside chat at…

USA Longtime Director of the Center for Drug Evaluation and Research CDER, Janet Woodcock, will be changing roles at the US Food & Drug Administration (FDA) and moving away from drug regulating. It is still unclear what her new role will entail. Rob Califf, the new FDA commissioner recently announced in…

USA In the United States, clinical trials have long been criticized for inadequate inclusion of minority patients and consequently for not representing the country’s diverse population. The FDA recently released new guidance for improving diversity in clinical trials. According to its Drug Trials Snapshots Report for 2019, of the clinical trials…

WHO Representatives from the US FDA, EMA, WHO and the pharma industry debated over the possible inclusion of environmental impact in future good manufacturing practice (GMP) inspections of drug production sites and the need for a new type of relationship between companies and regulators. We need more information and data to…

USA When the FDA gave Novartis the historic green light for Kymriah – the first gene therapy approved in the United States – in 2017, the agency declared that it was “ushering in a new approach” to the treatment of cancer and other serious and life-threatening diseases. Today, more than 20…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

USA Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of…

Global One of the enduring conundrums around ground-breaking and potentially paradigm-shifting treatments such as CAR-T is the ever-thorny question of how fast to move them to market when the promise seems so great, but the evidence remains so patchy.   So far, top tier regulators such as the US FDA and…

USA Almost ten months into his presidency, Joe Biden has announced his pick to lead the US Food and Drug Administration (FDA). If confirmed by the Senate, the nominee, Dr Robert Califf, would become commissioner for a second time after leading the agency for almost a year at the end of…

Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…

Saudi Arabia 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 Vision 2030 national plan. As Saudi transitions away from oil towards becoming a knowledge-based economy, it is hoping to attract ever more international pharma companies to…

USA Writing in the May edition of DIA’s Global Forum magazine, Erica Lyons, Sarrit Kovacs, Matthew Kowalik, and Jessica Lee from the Division of Gastroenterology, Office of New Drugs, CDER at the US FDA look at how patient input is increasingly being utilised in new drug development, its importance in assessing…