Blog
RSS FeedPosted by Michael Wonder on 25 Feb 2022
Assessment of public opinion on transparency at the US Food and Drug Administration
18 February 2022 - Historically, the US FDA has considered much of the oversight of clinical trials, interactions with companies, and ...
Posted by Michael Wonder on 25 Feb 2022
Updating the Bayh-Dole Act; march-in rights and transparency
24 February 2022 - The Patent and Trademark Law Amendments Act (Bayh-Dole Act [35 USC §200-212]) was enacted in 1980 and ...
Posted by Michael Wonder on 19 Feb 2022
FDA eyes second COVID-19 booster shot
19 February 2022 - The agency has begun reviewing data that could lead to clearing a second booster dose of ...
Posted by Michael Wonder on 19 Feb 2022
FDA’s Califf shares priority list with agency staff
18 February 2022 - Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for ...
Posted by Michael Wonder on 17 Feb 2022
Dr. Robert Califf returns as FDA's Commissioner
17 February 2022 - The Stakeholder Engagement Staff is pleased to announce the swearing in of Dr. Robert Califf this afternoon, ...
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
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
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 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
Eli Lilly promises 40% discount for Innovent’s PD-1 in last-ditch bid to shift FDA review to drug pricing
10 February 2022 - Eli Lilly has been talking up a “disruptive” pricing strategy for its Innovent Biologics partnered PD-1 ...
Posted by Michael Wonder on 09 Feb 2022
FDA raises concerns about China developed drugs
9 February 2022 - Agency could slow the plans of big Western drugmakers to sell Chinese tested medicines in U.S. ...