The guidance focuses on the best ways to detect new cases, test for the virus and stop its transmission. The EU's Emergency Response Coordination Centre is also on high alert. It can provide logistical support for the transporting of medicines, vaccines or specialized equipment. ...
In the EU, they can fall under the category of borderline products, i.e., complex healthcare products for which there is uncertainty over the applicable regulatory framework, and were national authorities classify them as either as medicines or as medical devices on a case-by-case basis74. ...
For veterinary medicines the accepted electronic format isVNeeSand NeeS and for ASMFs also exceptionally eCTD is allowed. More information can be found from theVeterinary Pre-submission guidance. Please take a note of the voluntaryEU ASMF Assessment worksharing. A differentEU/ASMF request formshould ...
Despite advances in medicines and treatments, there's one simple fact that has never changed: prevention is better than a cure. It is the reason countries invest in vaccines. However, hospitals are struggling to tackle the silent epidemic of healthcare-associated infections. ...
Many bacterial lysates have been used for medical purposes, but there is a clear need for more robust clinical trials. For example, a report by the European Medicines Agency (EMA) describes the assessment of eight different lysates developed for respiratory conditions31. The report provides a ...
Capital Hill’s new legislation reflected biotech became a new focus in U.S.-China tech rivalry, American news website Axios commented at the weekend. The site stressed the market for biologically engineered and produced materials, medicines, fuel and food could be worth between $4 trillion and...
“Our vision for the company is to develop medicines for life-altering conditions. The type of heart failure we treat is very much life-threatening. In our trial we’re treating people with a life expectancy of less than a year. “So the market potential for our drug is probably in the...
Still, for at least one organization, the Dutch turned on the charm. The morning after the 2016 Brexit vote, Noël Wathion woke up in London with more reason than most to be anxious. Wathion is deputy executive director of the European Medicines Agency (EMA), a bureau analogous to the...
Capital Hill’s new legislation reflected biotech became a new focus in U.S.-China tech rivalry, American news website Axios commented at the weekend. The site stressed the market for biologically engineered and produced materials, medicines, fuel and food could be worth between $4 trillion and...
Capital Hill’s new legislation reflected biotech became a new focus in U.S.-China tech rivalry, American news website Axios commented at the weekend. The site stressed the market for biologically engineered and produced materials, medicines, fuel and food could be worth between $4 trillion and...