PDUFA reauthorization agreement sets up fiscal 2020 as milestone for weaving active surveillance into drug review – and for keeping sponsors informed of activities that affect their products.
The PDUFA VI user fee agreement negotiated by FDA and industry envisions the year 2020 as a critical milestone for FDA’s Sentinel active surveillance system: that is when the agency is committing to integrate Sentinel “into the human drug review program in a systematic, efficient and consistent way.”
The deadline is articulated via three specific deadlines outlined in Section I.K.1 of the "commitment letter" released by...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
