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RSS FeedPosted by Michael Wonder on 16 Feb 2022
The new lightning rod in the fight over high drug prices
16 February 2022 - With the BBB Act on the ropes, some drug pricing advocacy organisations are turning their attention to ...
Posted by Michael Wonder on 16 Feb 2022
Merck struggles to win European approval for Covid antiviral pill
16 February 2022 - EMA said to be unlikely to grant marketing authorisation to molnupiravir this month after ‘problematic’ data. ...
Posted by Michael Wonder on 16 Feb 2022
3D printing medical devices: stakeholders weigh in on FDA’s discussion paper
15 February 2022 - The US FDA has started thinking about how 3D printing of medical devices at the point ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 15 Feb 2022
Human medicines: highlights of 2021
15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...
Posted by Michael Wonder on 15 Feb 2022
Maine could lower cost of prescription drugs under new bill
15 February 2022 - An online public hearing for LD 1636 is being held on 15 February. ...
Posted by Michael Wonder on 15 Feb 2022
Biogen Alzheimer drug row augers flux in fast FDA approvals
14 February 2022 - Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation ...
Posted by Michael Wonder on 15 Feb 2022
Senate confirms Califf as FDA chief in tight vote
15 February 2022 - The narrow 50-46 decision underscored the divisions on both sides of the aisle over agency policies on ...
Posted by Michael Wonder on 15 Feb 2022
N.J. Governor Murphy outlines plan to lower prescription drug prices
14 February 2022 - New Jersey Governor Phil Murphy is promoting a legislative package aimed at lower prescription drug costs ...
Posted by Michael Wonder on 15 Feb 2022
With no votes to spare, Senate advances Califf’s FDA nomination toward final vote
14 February 2022 - In a dramatically close procedural vote Monday night, the Senate voted 49-45 to advance Robert Califf’s ...
Posted by Michael Wonder on 14 Feb 2022
Confirmation fight over Biden's FDA nominee comes to a head
14 February 2022 - An intense confirmation battle over Robert Califf, President Biden’s nominee to lead the FDA, is poised ...
Posted by Michael Wonder on 14 Feb 2022
U.S. consumer agency schedules meeting on drug prices
11 February 2022 - The U.S. Federal Trade Commission will consider at its upcoming meeting new orders for large pharmacies ...
Posted by Michael Wonder on 13 Feb 2022
The FDA and its new commissioner must follow the science
13 February 2022 - The FDA has the awesome responsibility to protect public health by ensuring the safety and effectiveness of ...
Posted by Michael Wonder on 12 Feb 2022
Industry cites outdated standards as flaw in FDA’s real world data draft guidance
11 February 2022 - The US FDA should adopt updated data standards that accommodate the “evolving and emerging” nature of ...
Posted by Michael Wonder on 10 Feb 2022
Patent box legislation to promote Australian innovation
11 February 2022 - Medicines Australia notes the introduction of patent box legislation, Treasury Laws Amendment (Tax Concession for Australian ...