Blog
RSS FeedPosted by Michael Wonder on 21 Aug 2017
FDARA: making a difference for industry and patients
21 August 2017 - For decades, user fees paid by the medical products industry have provided critical resources needed to ...
Posted by Michael Wonder on 20 Aug 2017
Trump quietly signs new FDA user fee agreement into law
18 August 2017 - President Trump on Friday quietly signed into law a sweeping measure that will help ensure the ...
Posted by Michael Wonder on 15 Aug 2017
Access to unregistered drugs in Australia
15 August 2017 - Drugs can usually only be prescribed for patients if they have been approved by the Therapeutic ...
Posted by Michael Wonder on 10 Aug 2017
Setting the record straight on FDA approvals in oncology
7 August 2017 - The Research Letter, “Quality of Life, Overall Survival and Costs of Cancer Drugs Approved Based on Surrogate ...
Posted by Michael Wonder on 10 Aug 2017
Science and innovation for better medicines
10 August 2017 - EMA leaflet shows how work of the Agency benefits patients. ...
Posted by Michael Wonder on 09 Aug 2017
Unlicensed and off-label uses of medicines: definitions and clarification of terminology
5 August 2017 - The terms “licensed”, “unlicensed”, and “off-label”, often used in relation to marketing and prescribing medicinal products, ...
Posted by Michael Wonder on 07 Aug 2017
Drugs cleared through the FDA’s expedited review offer greater gains than drugs approved by conventional process
7 August 2017 - Chambers et al. investigated whether drugs approved by the FDA through expedited review have offered larger ...
Posted by Michael Wonder on 06 Aug 2017
FDA’S generic drug labelling rule delayed again
4 August 2017 - The FDA won’t be issuing a controversial final rule on label changes concerning generic drug safety ...
Posted by Michael Wonder on 04 Aug 2017
Senate passes F.D.A. funding and ‘right to try’ drug bills
3 August 2017 - The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, ...
Posted by Michael Wonder on 02 Aug 2017
Senate plans to vote on FDA user fees legislation this week, senators say
1 August 2017 - The Senate will vote this week on a key legislative priority for the pharmaceutical industry and ...
Posted by Michael Wonder on 01 Aug 2017
EMA prepares for Brexit
1 August 2017 - Business continuity plan aims to preserve Agency’s ability to protect public and animal health ...
Posted by Michael Wonder on 31 Jul 2017
EU states set for squabble over who gets London's agencies after Brexit
1 August 2017 - Almost all EU countries are likely to bid to host the two major regulatory agencies that ...
Posted by Michael Wonder on 29 Jul 2017
Concept paper on development and lifecycle of personalised medicines and companion diagnostic
28 July 2017 - Public consultation to end on 31 October 2017. ...
Posted by Michael Wonder on 27 Jul 2017
FDA announces new steps to empower consumers and advance digital health care
27 July 2017 - When people think about personalised medicine, they often think of genetic testing and sequencing of the human ...
Posted by Michael Wonder on 27 Jul 2017
FDA sets inaugural meeting of first-ever patient engagement advisory committee
25 July 2017 - Imagine checking your blood sugar levels several times a day with a glucose meter to keep your ...