Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2020
Regulatory information - 1.6% increase in fees from 1 April 2020
1 April 2020 - General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on ...
Posted by Michael Wonder on 01 Apr 2020
Authorised nurse practitioners now eligible to prescribe certain Highly Specialised Drugs
1 April 2020 - From 1 April 2020, authorised nurse practitioners can prescribe hepatitis B, hepatitis C and HIV medicines ...
Posted by Michael Wonder on 31 Mar 2020
Expanded access as a source of real‐world data: an overview of FDA and EMA approvals
22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...
Posted by Michael Wonder on 31 Mar 2020
1 April 2020 price disclosure confirmed prices
31 March 2020 - Confirmed 1 April 2020 prices resulting from the 2020 April cycle of price disclosure have been published ...
Posted by Michael Wonder on 30 Mar 2020
FDA on signing of the COVID-19 Emergency Relief Bill, including landmark over-the-counter drug reform and user fee legislation
30 March 2020 - On Friday, the President signed into law a $2 trillion emergency relief bill that will continue ...
Posted by Michael Wonder on 30 Mar 2020
EMA to issue electronic certificates for medicines
30 March 2020 - EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. ...
Posted by Michael Wonder on 25 Mar 2020
FDA announces funding opportunity to explore the use of real-world data to generate real-world evidence in regulatory decision making
25 March 2020 - The U.S. Food and Drug Administration is announcing a funding opportunity for projects to support the ...
Posted by Michael Wonder on 25 Mar 2020
Treating COVID-19—off-label drug use, compassionate use, and randomised clinical trials during pandemics
24 March 2020 - In the 2014 Ebola outbreak, close to 30 000 individuals developed Ebola viral disease, and numerous therapies were ...
Posted by Michael Wonder on 24 Mar 2020
New restrictions on prescribing hydroxychloroquine for COVID-19
24 March 2020 - In recent days there has been considerable focus on the potential for hydroxychloroquine and the similar ...
Posted by Michael Wonder on 23 Mar 2020
Coronavirus (COVID-19) update: FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency
22 March 2020 - Today, as part of the U.S. FDA’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency ...
Posted by Michael Wonder on 23 Mar 2020
Insulin gains new pathway to increased competition
23 March 2020 - Today is a historic day and a landmark moment for patients with diabetes and other serious medical ...
Posted by Michael Wonder on 23 Mar 2020
Determinants of orphan drug prices in Germany
21 March 2020 - Legislation introduced in 2011 in Germany has instituted an early benefit assessment of newly licensed pharmaceuticals with ...
Posted by Michael Wonder on 19 Mar 2020
Limits on dispensing and sales of prescription and over-the-counter medicines
19 March 2020 - In order to ensure equitable access to medicines for all Australians, the Pharmacy Guild of Australia ...
Posted by Michael Wonder on 19 Mar 2020
Limits on dispensing and sales of medicines
19 March 2020 - Medicine supplies in Australia are strong however demand for medicines has increased markedly over the past two ...
Posted by Michael Wonder on 18 Mar 2020
Coronavirus (COVID-19) update: FDA focuses on safety of regulated products while scaling back domestic inspections
18 March 2020 - Protecting the health and safety of our staff and their families is of paramount concern to ...