In this week’s news, US FDA advises on Covid-19 trials, biotech VC investment soars and more…
US FDA issues safety advice for Covid-19 related trials
The US FDA has updated guidance on participant safety in Covid-19 related studies.
The regulator announced the revised guidelines last week, explaining it is based on examination of multiple proposed clinical trials.
“FDA has been careful to assess whether proposed COVID-19 therapies in research proposals have potential safety concerns that might exacerbate the most serious and life-threatening symptoms of COVID-19 patients, such as respiratory adverse effects or pro-inflammatory immune response.”
The FDA also said several trials had not been approved including those where animal data did not indicate the candidate had an appropriate safety profile, and those where the candidate amplified cytokine response.
CBER withdraws 80s guidance documents
In other FDA news, the Center for Biologics Evaluation and Research has withdrawn several guidance documents.
The withdrawn guidance documents, many of which date back to the early 1980s, are deemed no longer necessary.
Several documents refer to blood and blood products, donor screening and HIV – which have been replaced by other regulations. Another document from 2003, is guidance on screening donors for SARS.
There is also a document on how drug companies should deal with the Y2K computer date change problem or “millennium bug.”
US plans to give FDA recall authority
The FDA 2021 budget Bill recently approved by a House subcommittee includes a provision to give the agency the power to order drug recalls.
In a press release the House Committee on Appropriations said the Bill had been amended to “gives FDA legal authority to require the recall of unsafe prescription and over-the-counter drugs.”
The Bill also includes provisions to earmark $70 million for medical product development acceleration. Influenza vaccine manufacturing technology would also receive additional funding.
EU urges drug companies to make sure they are compliant post-Brexit
The European Commission, European Medicines Agency and Heads of Medicines Agencies reminded trial sponsors they must comply with EU trial rules following the Brexit transition period.
The organisations issued a readiness note last week. They wrote that after the transition period ends on December 31 sponsors must have a qualified person in the EU or European Economic Area.
In addition they pointed out the sponsor or a legal representative must be established in the EU to ensure smooth operation of ongoing studies.
Rising Interest in Alternative Packaging Following a Shortage of Glass Vials
Polyplastics USA says interest in cyclic olefin copolymer (COC) has increased as drug companies look for alternatives to borosilicate glass, which is in short supply following the development in Covid-19 vaccines.
The company confirmed that it is being used in ongoing testing applications and further developments are in the works for its use in new vaccines and therapies.
Topas COC is ideal for diagnostic disposables and packaging vaccines due to its low leachables and extractables and also its non-polar and low reactivity surface. Topas COC’s global regulatory compliance along with many other beneficial attributes make it a viable solution to a shortage of glass vials. Read more at Packaging Digest.