Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2021
New legislation to support medicine substitutions
5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...
Posted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
Posted by Michael Wonder on 04 Mar 2021
FDA releases a new plan to bring its data skills up to speed
4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...
Posted by Michael Wonder on 03 Mar 2021
Paying for prescription drugs in the new administration
2 March 2021 - In a national survey in January 2020 involving 1011 participants, the second-ranked domestic priority for members of ...
Posted by Michael Wonder on 02 Mar 2021
Drug industry pushes FDA to solve growing inspection backlog
2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
Posted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 25 Feb 2021
Three steps can help companies speed FDA approval of new drugs
24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...
Posted by Michael Wonder on 24 Feb 2021
TGA reviewing COVID-19 tests to rule out issues diagnosing variants
24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...
Posted by Michael Wonder on 23 Feb 2021
TGA bans Pfizer, AstraZeneca brand mentions in COVID-19 vaccine advertising
24 February 2021 - Pharmacies, GPs and healthcare organisations will be banned from displaying advertisements identifying whether they are using ...
Posted by Michael Wonder on 23 Feb 2021
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures
24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...
Posted by Michael Wonder on 23 Feb 2021
Epilepsy drug deaths: Medsafe told PHARMAC it was 'not desirable' to switch brands
23 February 2021 - The medicines safety authority advised PHARMAC it was “not desirable” for patients to switch brands of ...
Posted by Michael Wonder on 22 Feb 2021
Proposal leaves surgeons bound by private health
23 February 2021 - Australians paying thousands of dollars a year in health insurance could have their access to life-changing ...
Posted by Michael Wonder on 22 Feb 2021
EMA publishes agenda for 22-25 February CHMP meeting
22 February 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Feb 2021
EMA plots earlier engagement with patient groups
19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...