A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
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Cenobamate’s application was based on a global clinical trials programme enrolling over 1,900 adults with uncontrolled focal-onset seizures.
The bill includes $80 million funding for the US FDA to continue their COVID-19 response efforts and extra powers to modernise over-the-counter drug regulation.
With concerns rising about medicine availability during the global COVID-19 coronavirus pandemic, European Pharmaceutical Review explores how the pharmaceutical supply chain is faring.
The FDA and EMA have announced which COVID-19 treatments and vaccines are currently in development, as well as how they are supporting clinical trials.
The European Medicines Agency (EMA) has advised consumers on how to recognise registered online pharmacies so they can avoid falsified medications.
The presence of female directors makes boards more likely to report lower-severity defects and faster to recall products with high-severity problems, suggests research.
The US FDA has granted approval to BMS for Zeposia, a once daily oral medication for the treatment of relapsing forms of multiple sclerosis.
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
India has stopped exporting the malaria drug Ipca (hydroxychloroquine), despite the FDA lifting its ban on imports due to its potential as a coronavirus treatment.
Gilead Sciences say they are confident they can maintain an expedited regulatory review timeline for remdesivir as a treatment for COVID-19 without Orphan Drug Designation (ODD).
Positive topline results have been announced from a Phase II trial of VENCLEXTA® (venetoclax) in combination with azacitidine in patients with acute myeloid leukaemia (AML).
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.