Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2022
The FDA needs to get ready to evaluate synthetic cells, the next generation of therapeutics
26 July 2022 - Expanding new medical treatments requires pushing — and sometimes breaking — the boundaries of what currently ...
Posted by Michael Wonder on 25 Jul 2022
FDA describes plans to expand remote regulatory assessments
22 July 2022 - The US FDA released draft guidance on Friday that formalises its plans for using remote regulatory assessments ...
Posted by Michael Wonder on 21 Jul 2022
FDA offers new guidance on therapeutic equivalence evaluations
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
Posted by Michael Wonder on 20 Jul 2022
FDA announces an Oncologic Drugs Advisory Committee meeting to discuss benefit/risk profile of Oncopeptides' Pepaxto
20 July 2022 - Oncopeptides today announces that the US FDA, has announced a forthcoming public advisory meeting of the ...
Posted by Michael Wonder on 12 Jul 2022
Iterum Therapeutics announces special protocol assessment agreement with the FDA
11 July 2022 - SPA supports protocol for Phase 3 clinical trial of oral sulopenem for the treatment of uncomplicated urinary ...
Posted by Michael Wonder on 12 Jul 2022
FDA rule would facilitate prescription to OTC switches but nix a third class of drugs
12 July 2022 - After a decade long wait, the FDA finally issued a proposed rule in late June that ...
Posted by Michael Wonder on 10 Jul 2022
Human genetics evidence supports two-thirds of the 2021 FDA approved drugs
8 July 2022 - In 2021, 50 drugs were approved by the FDA’s Center for Drug Evaluation and Research, continuing a ...
Posted by Michael Wonder on 07 Jul 2022
Accelerated approval - taking the FDA’s concerns seriously
6 July 2022 - User-fee re-authorisation creates new opportunities for the FDA to address issues with its accelerated-approval program, including the ...
Posted by Michael Wonder on 30 Jun 2022
From FDA to MHRA: are drug regulators for hire?
29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...
Posted by Michael Wonder on 26 Jun 2022
US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...
Posted by Michael Wonder on 26 Jun 2022
Amryt to pursue formal dispute resolution for Oleogel-S10 (Filsuvez) NDA
24 June 2022 - Amryt today announces that the company plans to submit a formal dispute resolution request for the ...
Posted by Michael Wonder on 20 Jun 2022
FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge
20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...
Posted by Michael Wonder on 16 Jun 2022
Former FDA officials call for more transparency for drug approvals
15 June 2022 - The US FDA needs to take a more proactive approach in combatting misinformation and communicating decisions to ...
Posted by Michael Wonder on 14 Jun 2022
FDA should step in to help spur AI/ML standards
13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...