Vol. 20 #4
Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]. Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria.
2023-05-25T11:03:00+01:00By Catrin Jackson
FDA approves first gene therapy to treat dystrophic epidermolysis bullosa patients – a condition sometimes called ‘butterfly skin’.
2023-05-18T12:58:00+01:00By Sabine Ruehle,
Janneke Westra-de Vlieger,
supportive members of the TOPRA Biotech and Clinical Trial SPIN groups
The EU CTR replaced the EU CTD on 31 January 2022, which impacts investigational medicinal products that fall under genetically modified organisms (GMO-IMPs).
2023-05-18T12:57:00+01:00By Harriet Edwards
The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.
2023-05-18T12:56:00+01:00By Michaela Sharpe
This article looks at a range of innovative non-animal test methods, including in vitro tests based on human and animal cells, genomic technologies and in silico modelling.
2023-04-06T07:57:00+01:00By Regulatory Affairs Workgroup SINDUSFARMA
Advanced therapy medicinal products (ATMPs) have recently advanced in development and are subject to regulation in some markets. This article summarises the regulatory framework for ATMPs in some of the markets where these requirements are in place: Argentina, Brazil, Europe, and the US.
2022-12-05T00:14:00+00:00By Nathalie Bourrit
Gene therapies are highly innovative products which have been approved only for the treatment of rare diseases so far. Changes in manufacturing processes during development as well as difficulties in gathering large clinical data sets explain the common challenges encountered by gene therapy developers to demonstrate the benefit of their ATMP.
2022-06-24T16:13:00+01:00By Daniela Drago, Danielle Helton Corwin
This continuing professional development supplement discusses the available meeting options for products regulated by CDER and CBER, which should help the reader select the appropriate avenue to receive the Agency’s advice and develop a viable regulatory interactions strategy.
2022-06-15T10:09:00+01:00By Ash Ramzan, Manfred Kurz, Claudia Sailer
This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.
2022-06-09T10:47:00+01:00By Alex Bloom, Natalie Thomas, Michael Sinks, Colin Gillis, Daniela Drago, Davina Stevenson
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
2022-03-21T09:12:00+00:00By Harriet Edwards
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…,
2021-11-23T13:30:00+00:00By Leslie Dowling
Tomáš Borán introduced the presenters, co-chair and panellists for this session, discussing the regulatory progress in delivering on the promise of advanced therapy medicinal products (ATMPS)
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