Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2021
Overall survival for oncology drugs approved for genomic indications
17 December 2021 - Drug approvals for genome-informed indications have been increasing in recent years, but it is unknown how many ...
Posted by Michael Wonder on 16 Dec 2021
The wild west of checkpoint inhibitor development
15 December 2021 - Although immunotherapy development has improved overall survival among patients with common cancers and has led to important ...
Posted by Michael Wonder on 15 Dec 2021
Califf sails through confirmation hearing for FDA job, despite tensions over opioids
14 December 2021 - Robert Califf escaped largely unscathed from a two-hour hearing Tuesday vetting him to be commissioner of ...
Posted by Michael Wonder on 09 Dec 2021
FDA issues draft guidance for industry, considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
9 December 2021 - The U.S. FDA issued a draft guidance for industry titled Considerations for the Use of Real-World Data ...
Posted by Michael Wonder on 09 Dec 2021
Consensus lacking on ‘value’ for new anti-cancer drugs
8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...
Posted by Michael Wonder on 07 Dec 2021
U.S. plans to fast track revamped COVID-19 vaccines
5 December 2021 - Study from South Africa suggests the fast-spreading Omicron variant might cause less severe illness than its predecessors. ...
Posted by Michael Wonder on 07 Dec 2021
Product approval and public health at the US Food and Drug Administration
6 December 2021 - Since the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, drug approval in ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
Posted by Michael Wonder on 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
Posted by Michael Wonder on 24 Nov 2021
The FDA's dysfunction is a public health crisis of its own
22 November 2021 - Earlier this month, President Biden tapped Dr. Robert Califf to lead the FDA. ...
Posted 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 ...