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FDA grants emergency use authorisation to blood purification system for COVID-19
A blood purification system to reduce cytokine storms in COVID-19 patients has been given emergency use authorisation by the FDA.
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Active air sampler market to value $130.7 million by 2026
The active air sampler market, led by Asia-Pacific, Europe and US, is expected to grow from its current value of $92 million at a CAGR of 5.1 percent.
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EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
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Collaboration to develop automated platform for environmental monitoring
An Irish partnership between academia and industry aims to develop a robotic method for automated environmental monitoring in bioprocessing.
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Exploring the latest developments in biomedical materials
Drug Target Review rounds up some of the latest developments in materials developed for medical applications, including hydrogels, implants and more.
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FDA warns company selling fraudulent COVID-19 products containing chlorine dioxide
The US Food and Drug Administration (FDA) issued the letter after finding the products contain chlorine dioxide, a powerful bleaching agent with potentially fatal side effects.
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Researchers develop nanotechnology to clean surfaces at atomic scale
A group of researchers has developed a nanotechnology with a single bristle controlled through electron microscopy that can clean surfaces.
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British manufacturers praise UK government for relaxed hand sanitiser rules
The British Contract Manufacturers and Packers Association (BCMPA) has said the UK government's changes to expedite production of hand sanitiser will aid in the fight against COVID-19.
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UK and Europe tackle false COVID-19 medicinal products
The MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.
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COVID-19 update: running clinical trials during the coronavirus pandemic
In the face of the coronavirus pandemic, restrictions and extreme situations may require changes to ongoing or upcoming clinical trials. These are the key recommendations from the EC, MHRA and FDA.
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FDA grants Orphan Drug Designation to phenylketonuria treatment
A new treatment called APR-OD031 has been given Orphan Drug Designation (ODD) by the FDA, for the treatment of phenylketonuria.
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Using fatty acids in oral formulations to improve drug delivery
Researchers have used triglyceride fatty acids to develop an oral formulation for drugs that are usually injected or taken intravenously.
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On the new EU MDR guidance for “significant change” and clinical evidence for software
Maurits Lugard, Josefine Sommer and Antoine Robin from Sidley Austin dissect the recently released EU guidance to accompany the MDR, on what a significant change is and how to collect clinical evidence for medical device software.
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EMA releases its regulatory strategy for next five years
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
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Dr Reddy’s recalls four lots of Phytonadione injectable emulsion in US
The FDA has announced that Dr Reddy's is recalling Phytonadione injectable emulsion because of complaints due to ampules breaking and shattering.
