Regulatory Rapporteur - April 2024 | Regulatory Rapporteur

Regulatory Rapporteur – April 2024

April 2024 – Contents
Improving outcomes with data
Data quality, governance and sharing to enable insights and decision-making
Unveiling the synergy of AI’s regulatory harmony in shaping the future of biopharmaceutical progress
Device submissions for combination products: a data-driven perspective
Navigating the future of medicinal product data exchange: understanding XEVMPD
Managing risks: successful clinical development in asthma
Choosing the right registration pathway for the China drug master file: an essential analysis of options

Parkinson’s drug slows progression of motor symptoms
A developmental drug has shown promise in slowing symptoms of motor deterioration in people with advanced forms of Parkinson’s.
Novel antibiotic receives EMA’s recommendation
The European Medicines Agency has recommended marketing authorisation for an antibiotic which can treat multidrug-resistant infections.
Modified skin bacteria treats tumours in mice
A study from Stanford Medicine has developed a promising method to treat cancer using a type of bacteria which is found on skin.
Cutting antibiotic usage reduces resistance levels
Cutting the use of antibiotics in both humans and animals has shown a reduction in antimicrobial-resistant bacteria.
Utah law to permit non-FDA-approved stem cell therapies
Utah has passed legislation that will allow patients to receive placental stem cell therapies without the need for FDA approval.
Cholera vaccine shortage puts millions at risk
The World Health Organization has declared a worldwide shortage of the oral cholera vaccine amid an upsurge in cases.

Researchers have developed a method that uses high-frequency radio waves to temporarily open bacterial cell walls to introduce new DNA.

A procedure to test for a precancerous condition of the oesophagus, which uses a novel medical device, is under trial in NHS England.

2024-04-13T00:05:00+01:00By Alan Booth

Vol.21 #4: In April 2024’s RegRapPod, host Alan Booth talks to Issue Editor James McCormick about all things data.

2024-02-02T00:05:00+00:00By Alan Booth

BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN

March 2024 – Contents
Diverse and dynamic regulation in the Asia Pacific region
Navigating the regulatory terrain down under: trends in Australia for 2024
Regulatory imperatives in chemistry, manufacturing, and control for biosimilars a comprehensive analysis
Can the Japanese phase I study be waived?
Overview of digital transformation in healthcare and initiatives in Japan
Clinical trial design – keeping up with innovation
New data protection for maximum residue limits

January 2024 – Contents
The increasing complexity of biological medicinal products
Navigating early drug development investment: a detailed guide to due diligence
A weight of evidence approach for the non-clinical evaluation of complex biologicals
Innovating and harmonising access and requirements amid the global regulatory challenges of biologics
Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
The changing face of oncology development – is cancer still ‘different’? A US perspective
Artificial intelligence in drug discovery

October 2023 – Contents
Veterinary medicines: the challenges of new regulation
Transition to the new QRD template for veterinary medicines: challenges and opportunities
Autogenous vaccines under Regulation (EU) 2019/6
Prequalification of veterinary vaccines and medicines
EMA activities related to antiparasitic veterinary medicinal products
Optimal materials selection in medical device development – a proactive biocompatibility approach