Blog
RSS FeedPosted by Michael Wonder on 07 Oct 2022
The critical role of academic clinical trials in paediatric cancer drug approvals: design, conduct, and fit for purpose data for positive regulatory decisions
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
Posted by Michael Wonder on 04 Oct 2022
Rare disease endpoint advancement pilot program
3 October 2022 - FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development ...
Posted by Michael Wonder on 04 Oct 2022
Split Real Time Application Review (STAR)
3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...
Posted by Michael Wonder on 28 Sep 2022
In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices
27 September 2022 - The FDA on Tuesday published a list of artificial intelligence tools that should be regulated as ...
Posted by Michael Wonder on 15 Sep 2022
FDA issues final rule on ‘right to try’ reporting requirements
14 September 2022 - Drug firms that agree to supply investigational medicines under the Right to Try Act must submit ...
Posted by Michael Wonder on 15 Sep 2022
FDA’s drug industry fees fuel concerns over influence
15 September 2022 - The pharmaceutical industry finances about 75% of the agency’s drug division, through a controversial program that ...
Posted by Michael Wonder on 13 Sep 2022
FDA finalises guidance on submitting RWD/RWE in application cover letters
13 September 2022 - To help better track submissions that include real world data and real world evidence, the US ...
Posted by Michael Wonder on 09 Sep 2022
Bausch Health responds to Norwich Pharmaceuticals tentative FDA approval for a 200 mg rifaximin
9 September 2022 - Bausch Health and its gastro-enterology business Salix Pharmaceuticals today responded to the US FDA's tentative approval ...
Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...
Posted by Michael Wonder on 07 Sep 2022
Statement by President Biden on FDA and CDC authorising updated COVID-19 vaccines
6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...
Posted by Michael Wonder on 07 Sep 2022
CDER and CBER accept first submission to ISTAND pilot program
7 September 2022 - The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have ...
Posted by Michael Wonder on 05 Sep 2022
Clinical trials: real world data plays early role in efforts to increase diversity
5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...
Posted by Michael Wonder on 02 Sep 2022
FDA still skeptical of ALS drug ahead of high stakes meeting
3 September 2022 - The U.S. FDA has posted another negative review of a closely watched drug for the deadly neurodegenerative ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...
Posted by Michael Wonder on 29 Aug 2022
FDA boldly bows to big pharma at Americans’ expense
29 August 2022 - A Wall Street Journal headline went this way: “Latest Covid Boosters Are Set to Roll Out ...