We are delighted to announce that our Managing Director Andrew Waddell and Head of Quality Assurance Shona Ross, have been invited to speak at a series of GLP and GCP for laboratories webinars, hosted by The QARP – Quality Assurance Research Professionals in Russia.
EMA concludes AstraZeneca’s Vaccine as being safe and effective
On 18th March 2021, following the suspension of use in several European countries, the European Medicines Agency (EMA) declared the AstraZeneca/Oxford University COVID-19 vaccine as safe and effective after an investigation into a potential link between the vaccine and blood clots in a small number of patients. The EMA’s Pharmacovigilance Risk Assessment Committee recommended updating the vaccine’s safety information and promoting awareness of potential risks. The EMA will continue to evaluate whether there is a causal link between the vaccine and the thrombotic events.
MHRA issues guidance on the return of on-site inspections
On 19th March 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on the return to on-site UK risk based GxP inspections. The MHRA will continue to use a combination of remote and on-site inspection approaches, and any on-site inspections will have to comply with the prevailing government guidance. It will continue to prioritise inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk.
EMA issues highlights from the CVMP Committee Meeting
On 19th March 2021, the EMA issued highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) on 16-18th March. Highlights include CVMP opinions on veterinary medicinal products, pharmacovigilance and the Minor Use, Minor Species (MUMS)/limited market.
FDA authorises first machine learning-based screening device to identify biomarkers indicative of COVID-19
On 19th March 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation. The Tiger Tech COVID Plus Monitor is intended for use by trained personnel to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19.
EMA issues highlights from the CHMP Committee Meeting
On 22nd March 2021, the EMA issued highlights from the Committee for Medicinal Products for Human Use (CHMP) on 22-25th February. Highlights include six new medicines recommended for approval, negative opinions on extensions of therapeutic indication, and the outcome of the Varilrix review.
EMA advises against use of ivermectin for the prevention or treatment of COVID-19
On 22nd March 2021, the EMA advised against the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data does not support its use for COVID-19 outside well-designed clinical trials.
FDA issues update on its ongoing COVID-19 response effort
On 23rd March 2021, the FDA announced more actions taken in its ongoing response effort to the COVID-19 pandemic.
Clinical Trial Investigator jailed for role in scheme to falsify clinical trial data regarding an asthma medication
A clinical investigator and study co-ordinator have been jailed for 5 years 3 months and 2 years 6 months respectively for inventing participants in a paediatric asthma trial in Florida. A third person will be sentenced on 16th April.
Issue Number: WN0003
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