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RSS FeedPosted 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 10 Nov 2021
KRPIA raises concern over HIRA’s cost effectiveness evaluation plan
10 November 2021 - Korea Research-based Pharma Industry Association (KRPIA) expressed concerns over HIRA's plan of evaluating a drug’s cost ...
Posted by Michael Wonder on 09 Nov 2021
Australia to wait for data from US children before clearing vaccine here
10 November 2021 - Australia’s top immunisation advisers will wait on safety data from at least several hundred thousand young ...
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 09 Nov 2021
A toxic drug price deal
8 November 2021 - The latest version of government price controls is barely better than the first. ...
Posted by Michael Wonder on 08 Nov 2021
The hurried push by Congress to address drug costs shouldn’t undermine the vast savings from generics and biosimilars
6 November 2021 - Americans rightfully expect Congress to address the ever increasing prices of brand-name prescription drugs. ...
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 07 Nov 2021
Biocom California opposes new drug pricing proposal as written
5 November 2021 - Biocom California, the association representing the California life science industry, issued the following statement regarding the ...
Posted by Michael Wonder on 07 Nov 2021
The prescription drug price negotiation plan in the Biden BBB Bill is not what it’s claimed to be
6 November 2021 - Earlier this week, the New York Times reported, with the headline, “Democrats Add Drug Cost Curbs ...
Posted by Michael Wonder on 07 Nov 2021
AstraZeneca pulls request for Swiss approval of COVID shot
5 November 2021 - AstraZeneca says it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the ...
Posted by Michael Wonder on 06 Nov 2021
Pharmaceutical Benefits Scheme continued dispensing arrangements
5 November 2021 - The Australian Government has extended the Continued Dispensing emergency arrangements until 30 June 2022, when they ...
Posted by Michael Wonder on 04 Nov 2021
Impact of Medicare only limits on drug prices
4 November 2021 - Congress is considering legislation that would set limits on drug prices through price negotiation for certain high-cost, ...
Posted by Michael Wonder on 03 Nov 2021
PhRMA statement on Democrats' drug pricing deal in reconciliation package
2 November 2021 - The following can be attributed to PhRMA President and CEO Stephen J. Ubl. ...