Blog
RSS FeedPosted 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Preterm birth drug withdrawn after 12 years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 ...
Posted by Michael Wonder on 23 Feb 2023
FDA continues important work to advance medical products for patients with rare diseases
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...
Posted by Michael Wonder on 21 Feb 2023
The FDA returns to its bad habits
20 February 2023 - The agency may nix a new treatment for a debilitating orphan disease. ...
Posted by Michael Wonder on 20 Feb 2023
Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...
Posted by Michael Wonder on 18 Feb 2023
Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn
17 February 2023 - In the aftermath of the FDA’s Aduhelm debacle, the agency’s neuroscience chief Billy Dunn has another ...
Posted by Michael Wonder on 16 Feb 2023
FDA to require diversity plan for clinical trials
16 February 2023 - US regulatory agency makes ‘big change’ to increase the number of participants from under-represented groups in drug ...