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RSS FeedPosted by Michael Wonder on 24 Nov 2021
Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies
23 November 2021 - Robert Califf, President Biden’s choice to lead the FDA, earned $2.7 million as an executive at ...
Posted by Michael Wonder on 24 Nov 2021
FDA nomination slips after Biden admin fails to send papers to Congress
23 November 2021 - The delay means that Califf is now unlikely to get a confirmation hearing until mid-December at the ...
Posted by Michael Wonder on 15 Nov 2021
New FDA chief will face COVID woes and calls for drug approval reform
12 November 2021 - After long delay, US President Joe Biden picks Robert Califf to once again head the US FDA. ...
Posted by Michael Wonder on 15 Nov 2021
Califf has lots of unfinished FDA business
15 November 2021 - Robert Califf, whom President Biden picked to lead the US. FDA, does not have much to show ...
Posted by Michael Wonder on 13 Nov 2021
Biden nominates Califf as FDA chief
12 November 2021 - President Joe Biden on Friday nominated former Commissioner Robert Califf to lead the FDA, in a ...
Posted by Michael Wonder on 13 Nov 2021
Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements
12 November 2021 - On 28 April 2021, the US FDA announced that it “issued its first Notice of Non-compliance to ...
Posted by Michael Wonder on 11 Nov 2021
Health tech questions await next FDA chief
10 November 2021 - Twenty months into the pandemic, the FDA remains consumed with vital decisions on coronavirus vaccines and treatments. ...
Posted by Michael Wonder on 09 Nov 2021
FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics
9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...
Posted by Michael Wonder on 08 Nov 2021
Why does the FDA want to stop improving medicines via patent ‘areas of concern’?
8 November 2021 - It’s hardly unprecedented for one federal agency to encroach on another’s turf. But the latest intra-executive-branch ...
Posted by Michael Wonder on 02 Nov 2021
I’ve worked with Robert Califf. He is the leader the FDA needs.
2 November 2021 - If the cascade of news reports are true, President Biden is finally about to name his choice ...
Posted by Michael Wonder on 27 Oct 2021
FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice
27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...
Posted by Michael Wonder on 27 Oct 2021
FDA, NIH and 15 private organisations join forces to increase effective gene therapies for rare diseases
27 October 2021 - The U.S. FDA, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organisations have partnered ...
Posted by Michael Wonder on 27 Oct 2021
Democratic senators raise concerns with potential FDA pick
26 October 2021 - Sens. Joe Manchin and Richard Blumenthal have concerns with President Biden’s rumoured nominee for the FDA, ...
Posted by Michael Wonder on 26 Oct 2021
Eyenovia announces reclassification of MydCombi as drug device combination product by FDA
25 October 2021 - Company received complete response letter with additional requests and is preparing necessary documents for expedited resubmission, ...
Posted by Michael Wonder on 25 Oct 2021
Biden speaks with potential FDA commissioner
25 October 2021 - President Joe Biden recently held a call with Dr. Rob Califf, the former FDA commissioner, who ...