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RSS FeedPosted 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Industry cites outdated standards as flaw in FDA’s real world data draft guidance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. ...
Posted by Michael Wonder on 06 Feb 2022
Importing oncology trials from China: a bridge over troubled waters?
4 February 2022 - On 10 February 2022, the US FDA's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a ...
Posted by Michael Wonder on 05 Feb 2022
Confirming the next FDA commissioner is a matter of national preparedness
5 February 2022 - The COVD-19 pandemic has shown in bold relief our lack of national preparedness in the realm of ...
Posted by Michael Wonder on 04 Feb 2022
Lawmakers grill key FDA official over controversial Alzheimer’s drug approval
3 February 2022 - The FDA can’t escape questions about Aduhelm. ...
Posted by Michael Wonder on 02 Feb 2022
Global consequences of the US FDA's accelerated approval of cancer drugs
1 February 2022 - The accelerated approval system is a fast track drug approval pathway created by the US FDA in ...
Posted by Michael Wonder on 01 Feb 2022
CDER explores series of draft guidances on real world data, real world evidence - drug information update
31 January 2022 - Collection and analysis of real world data continue to gain traction in the biomedical community, accompanied by ...
Posted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 26 Jan 2022
Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA
27 January 2022 - Pfizer wants to intervene in a Texas federal lawsuit seeking information from the U.S. FDA used ...
Posted by Michael Wonder on 25 Jan 2022
Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
24 January 2022 - In light of the most recent information and data available, today, the FDA revised the authorizations ...
Posted by Michael Wonder on 24 Jan 2022
FDA considers limiting authorisation of certain monoclonal antibody treatments
23 January 2022 - Federal regulators are considering limiting the authorisation of certain monoclonal antibody treatments that have not proved ...