Tagged with FDA

USA Peter Marks, the US FDA’s top official for vaccines and cell and gene therapies, has resigned. A survivor of the first Trump administration, when his office faced intense pressure to fast-track COVID vaccine approvals, Marks reportedly clashed with new Health and Human Services Secretary Robert F. Kennedy Jr. and his…

Global In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with regulators worldwide to uncover the key regulatory trends shaping the future of healthcare in 2025 and beyond.   The Road…

USA While the year’s tally of green lights from the FDA’s Center for Drug Evaluation and Research (CDER) is lower than the previous year’s, 2024 saw several long-awaited therapies reach the finish line. Oncology remained the single largest focus area among last year’s endorsed therapies and as opposed to 2023 when…

USA For those concerned that opinion and not science may determine US public health policy under president-elect Trump, the choice of surgeon Martin Makary as head of the FDA may be reassuring. While Makary is known as a healthcare critic, his views appear to be far less extreme than the controversial…

USA In a country characterised by its racial and ethnic diversity, but where less than 5 percent of clinical trial data includes racial and ethnic factors, clinical trial diversity has become a key issue for the US FDA. Drug and medical device makers recognise the importance of diversity but find their…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

India US FDA India Office Director Sarah McMullen discusses the importance of maintaining India’s role as a global supplier of low-cost generics while also navigating the complexities of innovating and producing more complex pharmaceutical products. She notes that increased product complexity will inevitably lead to more regulatory challenges, emphasizing the need…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

USA The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of…

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Saudi Arabia The Saudi Food and Drug Authority (SFDA) has joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aimed at harmonising inspection procedures worldwide. Through PIC/S membership the SFDA looks to continue bolstering its capabilities and further its international collaboration efforts.   SFDA’s accession to PIC/S is one of the strategic projects of…

USA During a panel discussion at the BIO International Convention, Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research (CBER) discussed the positive regulatory outcomes of the COVID-19 pandemic as well as the backlogs it created and the challenges of carrying the lessons learned forward.   At…