All FDA articles
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CommentaryCell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
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JournalWarning letters for direct-to-consumer advertising: a five-year retrospective analysis
Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...
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JournalEU versus Rest of the World regulatory frameworks and requirements for human tissue-based products
After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and ...
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Industry newsFDA's Emerging Technology Programme
The FDA’s Emerging Technology Programme intends to assist industry in gaining regulatory approval for innovative technology drug applications.
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Industry newsTwo paediatric type 2 diabetes oral drugs receive FDA approval
FDA approves Jardiance and Synjardy as treatments to improve the control of blood sugar in children aged 10 years and older, with type 2 diabetes.
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JournalA critical review and comparison of the processes when seeking scientific advice in the EU and the USA – Part 1
GRAY, MSc − PART ONE OF A TWO-PART SERIES(See part 2 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory Agencies such as EMA and FDA regard provision of SA as a core ...
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Industry newsGene therapy gives hope to patients with ‘butterfly skin’
FDA approves first gene therapy to treat dystrophic epidermolysis
bullosa patients – a condition sometimes called ‘butterfly skin’. -
Industry newsFDA licence for first drug to treat agitation in Alzheimer’s
Rexulti has become the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease.
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Industry newsFDA approves world’s first RSV vaccine for use in over 60s
A first vaccine, developed by GSK, for respiratory syncytial virus has been approved by the FDA for use in adults aged 60 years and older.
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JournalAccelerated regulatory pathways: Vaccines for tropical diseases
Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.
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JournalHM3: Lessons learned and strategic priorities
The profession needs to adapt to the power of technology and the widespread dissemination of misinformation on social media is causing real-world harm.
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JournalBreakthrough therapy designation: From serious diseases to opioid crisis prevention
Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...
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JournalThe power of collaboration
Katherine Tyner, FDA Liaison to the EMA, Office of Global Policy and Strategy, FDA, discusses her position as a primary point of contact between the world’s two most important Agencies, and the goals they share for the future of public health.
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JournalUS FDA CDER and CBER guidance of interest
The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...