Blog
RSS FeedPosted by Michael Wonder on 16 Sep 2023
FDA’s final breakthrough devices guidance now includes technologies that address health disparities
15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program ...
Posted by Michael Wonder on 15 Sep 2023
EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
15 September 2023 - The CHMP has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine ...
Posted by Michael Wonder on 13 Sep 2023
FDA proposes changes to key approval pathway for medical devices, five years after promising
12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, ...
Posted by Michael Wonder on 30 Aug 2023
Withdrawn accelerated approvals for cancer indications in the US: what is the marketing authorisation status in the EU?
30 August 2023 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US FDA since 1992 ...
Posted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 22 Aug 2023
Swiss drug review times trail FDA and EMA, increased due to COVID
21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...
Posted by Michael Wonder on 16 Aug 2023
In a rare move, FDA threatens to fine a company for failing to report clinical trial results
16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...
Posted by Michael Wonder on 02 Aug 2023
Changes in the number of continuation patents on drugs approved by the FDA
1 August 2023 - Brand name pharmaceutical manufacturers often sustain high prices in the US by obtaining patents that delay generic ...
Posted by Michael Wonder on 01 Aug 2023
Stakeholders want clearer terms in FDA's generally accepted scientific knowledge guidance
31 July 2023 - Drug makers and research groups are generally supportive of the US FDA’s plan to allow greater flexibility ...
Posted by Michael Wonder on 28 Jul 2023
CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change ...
Posted by Michael Wonder on 20 Jul 2023
OPEN framework extended to a wider range of medicines
20 July 2023 - EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a ...
Posted by Michael Wonder on 10 Jul 2023
Association of Advisory Committee votes with US FDA - a decision-making on prescription drugs (2010-2021)
11 July 2023 - In this qualitative study of 409 advisory committee meetings, overall, 88% of FDA regulatory actions aligned ...
Posted by Michael Wonder on 10 Jul 2023
TGA decision on access to medical terminations
11 July 2023 - The Government welcomes the TGA’s decision to remove a number of restrictions on health professionals who ...
Posted by Michael Wonder on 07 Jul 2023
Phasing out of extraordinary COVID-19 regulatory flexibilities
6 July 2023 - EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the ...
Posted by Michael Wonder on 06 Jul 2023
Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study
5 July 2023 - The objective was to analyse the therapeutic value of supplemental indications compared with first indications for ...