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product safety

This page shows the latest product safety news and features for those working in and with pharma, biotech and healthcare.

FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

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

Latest news

  • FDA rejects ViiV’s long-acting monthly HIV injection FDA rejects ViiV’s long-acting monthly HIV injection

    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.

  • Trump administration advances drug importation plan Trump administration advances drug importation plan

    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 to present new data on Spinraza rival Roche to present new data on Spinraza rival

    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

  • Advaxis shaken by another FDA hold on cervical cancer vaccine Advaxis shaken by another FDA hold on cervical cancer vaccine

    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

  • Biogen and AbbVie pull MS drug Zinbryta from the market Biogen and AbbVie pull MS drug Zinbryta from the market

    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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Latest Intelligence

  • Achieving an agile supply chain Achieving an agile supply chain

    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

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    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

  • Biologic or biosimilar: what are prescribers thinking? Biologic or biosimilar: what are prescribers thinking?

    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

  • AI’s potential in the pharma life cycle AI’s potential in the pharma life cycle

    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

  • Managed Access Programmes: a powerful source of real-world insight Managed Access Programmes: a powerful source of real-world insight

    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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Latest appointments

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Latest from PMHub

  • Real-world evidence: breaking boundaries in rare disease

    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

  • Why are new medicinal products denied reimbursement in France? Why are new medicinal products denied reimbursement in France?

    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

  • The story behind Chloe Mitchell

    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

  • A Bitter Pill?

    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

  • Using new technologies to capture the patient's voice

    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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COVID-19 Updates and Daily News

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The Good Ideas Group

Remarkable but responsible creative work. We're most passionate about the pursuit of original, powerful ideas that our clients can harness...

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