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Regulatory Rapporteur – May 2023

May 2023 – Contents
Mind the gap:
Innovation vs
regulation of ATMPs
G-E-T-ting there – how gene editing technologies could change more than genes
Alternatives to animal testing
in the development of ATMPs
Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR
Ensuring promotional
materials’ compliance
in the EU
Regulatory guidelines for
nutraceuticals in India

Latest news

Illegal vapes found
to contain lead and
nickel: TOPRA Fellow
Inter Scientific - founded by TOPRA Fellow David Lawson - tests vapes confiscated from school children as part of BBC News investigation.
Gene 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’.
HIV-prevention drug is first to be made in South Africa
Indian firm Cipla is first manufacturer approved to produce generic of the
HIV-preventer cabotegravir, in South Africa.

Novel gene editing method “roughly threefold” better

Researchers from the University of California Santa Barbara (UCSB) have found two ways to boost the capabilities of CRISPR/Cas9.

Changing of the guard at Regulatory Rapporteur

Leslie Dowling, Editor-in-Chief of the Regulatory Rapporteur, for 12 years steps down:
Davina Stevenson set to take on lead of respected journal.

FDA 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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Conversations:
Regulating Vaxzevria:
The world’s first COVID-19 vaccine

Vol. 20 #4
MEMBER EXCLUSIVE:
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.