Tagged with FDA

New FDA Leadership Must Champion Generics & Biosimilars

USA New FDA Leadership Must Champion Generics & Biosimilars

USA A sustainable market for generics and biosimilars is the key to lowering the cost of medicine in the US, says John Murphy III, President and CEO of the Association for Accessible Medicines. Following leadership changes within the FDA, actively prioritizing generic and biosimilar medicines must remain a top focus…

Cell & Gene Therapy: Taiwan’s Second Mover Advantage

Taiwan Cell & Gene Therapy: Taiwan’s Second Mover Advantage

Taiwan In recent years, Taiwan’s policymakers have been aggressively deploying a multi-layered industrial strategy – and doing so with the benefit of watching earlier regional movers stumble – in an effort to transform the island into a premier global hub for Cell and Gene Therapy (C&GT) manufacturing and development. This state-driven…

Curative, Approved & Out of Reach: Cell & Gene Therapy’s Access Reckoning

USA Curative, Approved & Out of Reach: Cell & Gene Therapy’s Access Reckoning

USA Cell and gene therapies (CGTs) can now cure diseases that were untreatable a decade ago, often with a single dose. Yet most eligible patients – even those in rich countries like the United States – will never receive them. In many cases, the science is already in place. However, high…

Denise Gavin – Director, Office of Gene Therapy & Steven Oh – Director, Office of Cellular Therapy and Human Tissue, OTP/CBER, FDA

USA Denise Gavin – Director, Office of Gene Therapy & Steven Oh – Director, Office of Cellular Therapy and Human Tissue, OTP/CBER, FDA

USA As cell and gene therapies move closer to broader clinical reality, questions around manufacturing, scalability, and regulatory flexibility are becoming just as important as the science itself. Denise Gavin and Steven Oh of the FDA’s Office of Therapeutic Products discuss how the agency is adapting its chemistry, manufacturing, and controls…

FDA Adrift: Leadership Chaos & What It Means for Drug Approvals

USA FDA Adrift: Leadership Chaos & What It Means for Drug Approvals

USA The US Food and Drug Administration (FDA) finds itself in the midst of unprecedented political turmoil. The Trump Administration’s Department of Government Efficiency (DOGE) removed 3,500 of the Agency’s 20,000 employees in 2025, and a relentless succession of leadership upheavals has compounded the disruption. After 17 months of regulatory and…

Vijay Kumar – Acting Director, Office of Therapeutic Products, CBER, FDA

USA Vijay Kumar – Acting Director, Office of Therapeutic Products, CBER, FDA

USA Vijay Kumar is the acting director of the Office of Therapeutic Products (OTP) within the FDA’s Center for Biologics Evaluation and Research (CBER), the regulatory super office established in 2023 to oversee the rapidly expanding cell and gene therapy landscape. With a mandate spanning gene therapies, stem cell and cell-derived…

Jaw-Jou Kang – Professor, National Yang Ming Chiao Tung University (NYCU); Chair, Taiwan Society of Regulatory Affairs for Medicinal Products

Taiwan Jaw-Jou Kang – Professor, National Yang Ming Chiao Tung University (NYCU); Chair, Taiwan Society of Regulatory Affairs for Medicinal Products

Taiwan Jaw-Jou Kang, Professor at NYCU, former head of Taiwan’s Food and Drug Administration and current chair of the Taiwan Society of Regulatory Affairs for Medicinal Products discusses the nation’s regulatory transformation, challenges in talent retention, advances in regenerative medicine frameworks, and Taiwan’s positioning within the global biopharmaceutical ecosystem whilst navigating…

Spearheading the Charge Against Rare Disease

USA Spearheading the Charge Against Rare Disease

USA The US rare and ultra-rare disease market constitutes a cornerstone of the worldwide pharmaceutical industry, representing a full 52.3 percent of the total global market share in revenue for that therapeutic area. America also plays an outsized role in driving international medical innovation in that field – housing nearly 60…

Paul Kim – Principal, Kendall Square Policy Strategies

USA Paul Kim – Principal, Kendall Square Policy Strategies

USA Paul Kim, a leading FDA attorney and policy expert formerly at both the FDA and the US Congress, discusses the current shifts within the American life sciences and regulatory landscape. Kim examines the prevailing sentiment of the industry amidst a period of significant structural upheaval and regulatory whiplash. He offers…

Sarah Yim – Director, Office of Therapeutic Biologics and Biosimilars, CDER, FDA

USA Sarah Yim – Director, Office of Therapeutic Biologics and Biosimilars, CDER, FDA

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

How Patient-Led Drug Development Has Transformed the US Rare Disease Ecosystem

USA How Patient-Led Drug Development Has Transformed the US Rare Disease Ecosystem

USA Patients and carers with lived experience of a disease have valuable insights to share with physicians and drug developers alike. This is especially true of rare diseases, defined in the US as those that affect fewer than 200,000 people nationwide and which collectively impact over 30 million Americans. For these…

USA Amy Comstock Rick – Director of Strategic Coalitions, FDA Rare Disease Innovation Hub

USA As rare disease science accelerates, regulators face growing pressure to adapt without compromising rigour. In this interview, Amy Comstock Rick explains how the FDA Rare Disease Innovation Hub is strengthening cross-centre coordination, evolving evidence expectations for ultra-rare conditions, and creating new spaces for dialogue between regulators, developers, and patients. The…

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