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RSS FeedPosted by Michael Wonder on 08 Nov 2023
FDA finalises guidance on real-time review of oncology drugs
7 November 2023 - The US FDA has finalised its guidance that outlines the eligibility and submission requirements for applicants interested ...
Posted by Michael Wonder on 04 Nov 2023
How should the FDA evaluate psychedelic medicine?
4 November 2023 - Drug companies are spending millions of dollars to incorporate psychedelic agents into health care. Working with ...
Posted by Michael Wonder on 04 Nov 2023
Key Senate panel to consider PBM, drug pricing reform package
2 November 2023 - A key Senate panel announced it will consider more policies to regulate pharmacy middlemen and ensure ...
Posted by Michael Wonder on 04 Nov 2023
Medicare is urged to consider Amgen patent manoeuvres when negotiating the price for a drug
31 October 2023 - As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues ...
Posted by Michael Wonder on 02 Nov 2023
The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture
1 November 2023 - After holding oversight roles for covid vaccines, two regulators from the US FDA went to work for ...
Posted by Michael Wonder on 02 Nov 2023
FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
1 November 2023 - There has been “continued growth” in the number of applications submitted to Project Orbis, and the ...
Posted by Michael Wonder on 01 Nov 2023
Landmark listing of first three countries as WHO listed regulatory authorities
31 October 2023 - The Health Sciences Authority, Singapore; the Ministry of Food and Drug Safety, Republic of Korea; and ...
Posted by Michael Wonder on 30 Oct 2023
Reforming pharmacy benefit managers - a review of bipartisan legislation
28 October 2023 - Policy makers are considering legislation that would address several well known problems with the pharmacy benefit management ...
Posted by Michael Wonder on 23 Oct 2023
We can’t let drug companies get out of negotiating prices
23 October 2023 - In recent months, drug manufacturers and their allies have filed 10 lawsuits attacking one of the Inflation ...
Posted by Michael Wonder on 12 Oct 2023
Life sciences leaders unite to condemn radical plans to rewrite medicines scheme
9 October 2023 - Over twenty industry leaders from companies supplying the NHS with essential medicines warn that radical plans to ...
Posted by Michael Wonder on 11 Oct 2023
Medicare may plan to negotiate drug prices, but some states are taking their own steps to lower costs
11 October 2023 - Anticipation may be high that Medicare can wring lower prices out of drug makers, but a ...
Posted by Michael Wonder on 11 Oct 2023
FDA establishes new advisory committee on digital health technologies
11 October 2023 - Today, the US FDA announced the creation of a new Digital Health Advisory Committee to help ...
Posted by Michael Wonder on 09 Oct 2023
TLV believes that the requirements for evidence in new EU legislation must be strengthened
9 October 2023 - The European Commission's proposal for a new regulation and directive has a decisive impact on the quality ...
Posted by Michael Wonder on 05 Oct 2023
Biden-Harris Administration moves forward with Medicare drug price negotiations to lower prescription drug costs for people with Medicare
3 October 2023 - 10 companies manufacturing some of the costliest prescription drugs to participate in first-ever direct negotiations with ...
Posted by Michael Wonder on 04 Oct 2023
Determining the right offer price in Medicare drug negotiations
22 September 2023 - By using data on therapeutic alternatives as the basis for an initial offer price, CMS is ...