Blog
RSS FeedPosted by Michael Wonder on 16 Oct 2022
Battle over pregnancy drug highlights risks of FDA expediting drugs to market
16 October 2022 - The year's long effort to yank the drug's approval offers a case study of the agency's accelerated ...
Posted by Michael Wonder on 15 Oct 2022
Impending relief for Medicare beneficiaries - the Inflation Reduction Act
15 October 2022 - For many Medicare beneficiaries, the Inflation Reduction Act will reduce out of pocket spending for retail prescription ...
Posted by Michael Wonder on 15 Oct 2022
Gottlieb, McClellan push for FDA regulatory reforms
14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...
Posted by Michael Wonder on 15 Oct 2022
Biden pushes HHS to do more on drug pricing
14 October 2022 - President Joe Biden plans to sign an executive order asking HHS to explore new ways to ...
Posted by Michael Wonder on 10 Oct 2022
Federal drug price watchdog consulting public on proposed changes to its pricing guidelines
7 October 2022 - The PMPRB's guidelines explain how its staff monitor and review patented medicine prices to ensure they are ...
Posted by Michael Wonder on 10 Oct 2022
Mental health funding of £1.8 million welcomed by NICE and MHRA to explore regulation of digital mental health tools
10 October 2022 - NICE and the MHRA have been awarded £1.8 million funding by Wellcome over three years to explore ...
Posted by Michael Wonder on 10 Oct 2022
High quality data to empower data-driven medicines regulation in the European Union
10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...
Posted by Michael Wonder on 09 Oct 2022
New federal incentives for diversity in clinical trials
8 October 2022 - In June 2022, the US House of Representatives passed legislation intended to increase the diversity of ...
Posted by Michael Wonder on 08 Oct 2022
The Inflation Reduction Act lowers health care costs for millions of Americans
5 October 2022 - Through the Inflation Reduction Act, President Biden is delivering on his promise to lower prescription drug ...
Posted by Michael Wonder on 08 Oct 2022
Senate Republican bill would repeal Democratic drug pricing law
7 October 2022 - Senate Republicans on Friday introduced a bill that would roll back the drug pricing reforms included in ...
Posted by Michael Wonder on 07 Oct 2022
Fulfilment of post-market commitments and requirements for new drugs approved by the FDA, 2013-2016
3 October 2022 - Pre-approval trials of investigational drugs have limited duration and size and often exclude certain populations. ...
Posted 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 06 Oct 2022
HHS implements inflationary rebates for list prices of Medicare Part D (outpatient) drugs
5 October 2022 - On 1 October, the Department of Health and Human Services began implementing one of three main prescription ...
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 ...