As part of critical preparedness efforts, the United States (US) Food and Drug Administration (FDA) have published a final guidance to assist sponsors in the clinical development of drugs for treatment and prevention of smallpox (variola virus) infection. Read more “FDA finalises guidance on smallpox drug development”
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Highlights from the November CHMP meeting 2019
From their meeting in November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the November CHMP meeting 2019”
The EMA has published important guidance on the clinical development of new gout treatments
The finalised guidelines show the European Medicines Agency’s (EMA) expectations of manufacturers involved in the clinical development of new urate-lowering therapies (ULTs) and anti-inflammatory treatments of gout. Read more “The EMA has published important guidance on the clinical development of new gout treatments”
The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals
An article published in Clinical Pharmacology & Therapeutics by the European Medicines Agency (EMA), describes the interactions needed between stakeholders to accelerate patient access to ground-breaking new therapies. Read more “The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals”
Calls for EU to streamline review times for ATMP clinical trials
“It is important to ensure that ATMP clinical trials are approved in the shortest possible time frames” said the Alliance for Regenerative Medicine (ARM). Read more “Calls for EU to streamline review times for ATMP clinical trials”
ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators
The results of a recent survey released by the International Council on Harmonisation (ICH) suggest that pharmaceutical companies and regulators around the world are adopting and adhering to its guidelines on quality, safety and efficacy in drug development. Read more “ICH survey shows greater regulatory harmonisation among pharmaceutical companies and regulators”
MDCG issues guidance on legacy device certification issues surrounding the new MDR
There has been growing concern among many manufacturers about how the new Medical Device Regulation (MDR) will affect currently marketed devices, also known as “legacy devices”. Read more “MDCG issues guidance on legacy device certification issues surrounding the new MDR”
The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications
The United States (US) Food and Drug Administration (FDA) is taking steps towards making electronic submission of safety reports for investigational new drug applications (INDs) into their Adverse Event Reporting System (FAERS), a requirement. Read more “The FDA plans to implement e-submission of safety reports for investigational new drug (IND) applications”
Biosimilar medicines: is further regulatory convergence required?
A biosimilar is a biological medicine which is highly similar, in terms of structure, activity, efficacy and safety, to another biological medicine (reference medicine) which is already approved by a regulatory authority. Read more “Biosimilar medicines: is further regulatory convergence required?”
The latest advancements on the use of artificial intelligence in drug development
Approximately 50% of late-stage clinical trials fail due to ineffective drug targets, meaning only 15% of drugs advance from Phase II trials to approval. Artificial intelligence (AI) can help to enhance drug development by making more accurate predictions in novel areas of biology and chemistry. Read more “The latest advancements on the use of artificial intelligence in drug development”