Blog
RSS FeedPosted by Michael Wonder on 08 Apr 2023
Federal judge stays FDA abortion pill approval, gives Biden administration time to appeal
7 April 2023 - A federal judge in Texas on Friday stayed the FDA’s approval of the abortion pill mifepristone, ...
Posted by Michael Wonder on 07 Apr 2023
FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena
6 April 2023 - Today, the US FDA announced the final decision to withdraw approval of Makena—a drug that had been ...
Posted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 02 Apr 2023
Ensuring public trust in an empowered FDA
1 April 2023 - The FDA’s recent approval of lecanemab for Alzheimer’s disease has been clouded by controversy over other accelerated ...
Posted by Michael Wonder on 29 Mar 2023
Medical device companies now need to prove to FDA they’re protected against cyber attacks
29 March 2023 - Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and ...
Posted by Michael Wonder on 21 Mar 2023
Top FDA official: agency needs to start using accelerated approval for gene therapies
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
Posted by Michael Wonder on 20 Mar 2023
Opioid settlement hinders patients’ access to a wide array of drugs
13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...
Posted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...
Posted by Michael Wonder on 08 Mar 2023
Preterm birth drug withdrawn after 12 years
7 March 2023 - The FDA seemed poised to rescind approval of Makena, after studies over time indicated the treatment did ...
Posted by Michael Wonder on 08 Mar 2023
The unique device identifier: a unique opportunity
7 March 2023 - A unique device identifier is an individualised alphanumeric signature associated with a single medical device. Since 2013, ...
Posted by Michael Wonder on 03 Mar 2023
Bipartisan senators introduce bill to close pharma competition loophole
1 March 2023 - Senators Maggie Hassan and Mike Braun on Wednesday reintroduced legislation intended to close a loophole that ...
Posted by Michael Wonder on 02 Mar 2023
FDA and FTC collaborate to advance competition in the biologic marketplace
2 March 2023 - In 2021 alone, the US spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions ...
Posted by Michael Wonder on 01 Mar 2023
A review of patient reported outcome considerations in Oncologic Drugs Advisory Committee meetings (2016-2021)
28 February 2023 - The purpose of this project was to gain insight into the role of patient reported outcome data ...
Posted by Michael Wonder on 27 Feb 2023
For Cytokinetics, an FDA rejection of its heart drug would help, not hinder
27 February 2023 - Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval. ...
Posted by Michael Wonder on 25 Feb 2023
AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data
23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to ...