This page shows the latest product safety news and features for those working in and with pharma, biotech and healthcare.
For an EUA to be authorised, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product,” said Hahn. ... We work with sponsors so that additional data about the product’s safety and
In the CRL, the FDA cited concerns regarding the treatment’s chemistry manufacturing and controls process, but there was no issues surrounding the safety of the product.
The proposal could prove difficult for other reasons, as it also requires importers to have knowledge of regulatory processes – including safety tests and being able to manage product recalls. ... The safety tests would need to be able to demonstrate
Roche is expected to present updated safety data for the survival motor neuron 2 (SMN2) splicing modifier at the AAN congress, along with one-year data from the dose-finding Part ... Risdiplam’s safety data could see Roche continue to build its case
The FDA hasn't cited any safety issues on this occasion, and enrolled patients will continue to receive treatment, but no new patients can enroll in AIM2CERV until the partial hold ... concluded, “Our Axal product has demonstrated a manageable safety
Escalating concerns about the safety of Zinbryta (daclizumab) - and particularly cases of liver damage and immune-related conditions - are behind the decision, which was announced on the same day that the ... Last November the EMA reported that it had
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Customer expectations with regards to product safety and hygiene are also creating new trends within product packaging, trends which reverse the shift away from plastic that has occurred over recent years. ... Andy Barrett is Senior Product Manager at
While Onpattro has outshone Ionis’ product in safety and efficacy, analysts see Onpattro’s lack of cardiovascular claims in its US label as a weak point. ... and sustainable clinical pipeline and a robust product engine by the end of 2020; a company
Provenance and product availability matter: Even with proven safety and efficacy, the origins of some biosimilars raise questions. ... Many companies (eg, from Asia) are unknown, and uncertainties around delivery capabilities and safety legislation
patient safety monitoring, artificial intelligence (AI) has substantial potential to change the way life sciences organisations operate. ... AI could also support a range of applications in product safety - for example, the use of algorithms to predict
These programmes therefore offer a unique opportunity to collect real-world data before launch, providing evidence to support the product's effectiveness, safety and value. ... Even simple points such as duration of treatment, reason for discontinuation,
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Previously, Dr Hoffman served as vice president of medical and scientific affairs at Covance and vice president of global medical affairs and product safety at Hospira.
Dreiøe has 20 years of experience in the biotech and pharmaceutical industries in quality, manufacturing, product safety and regulatory affairs.
He was global head of safety operations at pharma company. Roche's Andrew Monaghan has swapped pharma for clinical research by moving to Chiltern. ... His strong leadership skills and extensive clinical experience will ensure our clients continue to
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The generation of data to show the significant benefits of a drug has always been a complex, intricate process, but essential to ensure a product’s approval, support the overall value ... Traditional randomized clinical trials (RCTs) are considered the
1. The SMR ratings, which are the focus of this blog post, are awarded based on a review of the severity of the disease, the medicinal product’s safety, efficacy/effectiveness ... Failure to meet the desired efficacy or safety thresholds cannot, due to
What attracted you to the Medical Communications industry? In my previous role in Patient Safety, my knowledge was product specific and I felt that Medical Communications would give me a broader ... My previous role in patient safety required 6–9
commonly find that route of admin is often one of the first features they take into account (after efficacy and safety) when reviewing product profiles, and getting it right is fundamental ... In conclusion, optimising the route of admin is a fundamental
world evidence that enables them to continue appraising the safety, efficacy and value of medicines over their full lifecycle. ... time. Trust (embracing such factors as perceived lack of transparency and product safety concerns), meanwhile, was
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