Blog
RSS FeedPosted by Michael Wonder on 19 Mar 2021
Too fast or too slow: is the FDA moving at the right speed?
19 March 2021 - Regardless of President Joe Biden’s choice for the next commissioner of the FDA, the Senate Health, Education, ...
Posted by Michael Wonder on 17 Mar 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of adults with active psoriatic arthritis
17 March 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 15 Mar 2021
Confirmation of Technigas US FDA timetable
12 March 2021 - Cyclopharm has provided an update of the US FDA’s timetable in respect of approval of the Company’s ...
Posted by Michael Wonder on 09 Mar 2021
Pandemic forces FDA to sharply curtail drug company inspections
9 March 2021 - The steep decline in oversight has stalled a number of new drug applications. ...
Posted by Michael Wonder on 02 Mar 2021
Drug industry pushes FDA to solve growing inspection backlog
2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...
Posted by Michael Wonder on 25 Feb 2021
Three steps can help companies speed FDA approval of new drugs
24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...
Posted by Michael Wonder on 17 Feb 2021
COVID-19 vaccine approval process: does it take too long?
15 February 2021 - Here are answers to some questions about the FDA review panels. ...
Posted by Michael Wonder on 29 Jan 2021
Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab
29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June ...
Posted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 07 Dec 2020
FDA could authorise Pfizer’s COVID-19 vaccine this week as U.S. deaths surge
7 December 2020 - An FDA advisory group is scheduled to convene on Thursday to review Pfizer’s vaccine. ...
Posted by Michael Wonder on 03 Dec 2020
Pushed to rush, FDA head says feds will get vaccine 'right'
2 December 2020 - The head of the agency responsible for authorising COVID-19 vaccines says it will take the time needed ...
Posted by Michael Wonder on 02 Dec 2020
Trump to meet next week with industry, government officials on COVID vaccine
2 December 2020 - President Donald Trump will gather leaders from industry and government next week for a summit on the ...
Posted by Michael Wonder on 28 Nov 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce extension of PDUFA date for pegunigalsidase alfa for the proposed treatment of Fabry disease
27 November 2020 - Protalix BioTherapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) ...
Posted by Michael Wonder on 25 Nov 2020
Pfizer vaccine distribution could kick off within weeks pending FDA approval, Azar says
24 November 2020 - A FDA panel will meet on 10 December to consider Pfizer’s emergency use authorisation application for its ...
Posted by Michael Wonder on 23 Nov 2020
COVID-19 shots could reach first Americans by mid-December, top health official says
23 November 2020 - U.S. health care workers and others recommended for the nation’s first COVID-19 inoculations could start getting shots ...