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Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
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US Food and Drug Administration (FDA)
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NDMA: a recall trigger for the drug development industry
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
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FDA issues emergency use authorisation for COVID-19 convalescent plasma
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
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FDA approves Kesimpta® (ofatumumab) for patients with relapsing multiple sclerosis
Kesimpta was approved based on trial results showing the monthly injection significantly reduced the relapse rate and disability progression of MS patients compared to a currently approved treatment.
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FDA releases guidance on bioavailability and bioequivalence study samples
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
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EMA accepts marketing application for Spinal Muscular Atrophy treatment
The European Medicines Agency (EMA) has accepted the marketing authorisation application for Evrysdi™ (risdiplam) as a treatment of spinal muscular atrophy (SMA).
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Researchers find three drugs on market that induce side effects in C. elegans
A study has found that three prescription drugs on the market cause unexpected side effects in the C. elegans worm, meaning they could have unknown effects in humans.
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COVID-19 vaccine: applying healthcare traceability learnings to ensure safe global distribution
Grant Courtney explains why traceability is vital for the current pandemic as it would guarantee that COVID-19 vaccines are safe, effective and suitably distributed.
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Post COVID-19: time for drug manufacturers and healthcare providers to rethink their strategies
Mike Owen details how supply chains have been disrupted by COVID-19 and why smart information management can offer a new source of renewed trust.
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FDA issues warning over subpotent and dangerous hand sanitisers
The FDA has updated its list of hand sanitisers to not use, including those with low levels of ethyl alcohol or isopropyl alcohol or with a dangerous presence of methanol.
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FDA approves Epidyolex for treatment of tuberous sclerosis complex-associated seizures
Epidyolex, a cannabidiol oral solution, has been given approval by the FDA to treat seizures associated with tuberous sclerosis complex (TSC).
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US invests over $240 million into seven new COVID-19 diagnostic tests
The National Institutes of Health in the US has awarded contracts to seven biomedical companies to develop and manufacture COVID-19 diagnostics.
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FDA proposes four APIs for bulk substances list for outsourcing facilities
Four APIs are being considered by the FDA for its bulk drug substances list for potential use by outsourcing facilities when compounding if there is a clinical need.
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Why pharma firms would benefit from a modular approach to working with product labelling
According to David Bennett, securing and building trust in the label, brand and process of a highly regulated industry player in a complex age will demand a new approach.
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Top 10 biopharma workplaces in the US
A Fortune report reveals the best 10 places to work in the US biopharmaceutical industry.
