RAPS Highlights

 

 

 

 

24 March 2023 | By Ferdous Al-Faruque
This Week at FDA: Becerra asks for new authorities; FDA issues guidances, reports

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device...

24 March 2023 | By Ferdous Al-Faruque
FDA outlines plan for digital health technologies for clinical trials

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health ...

24 March 2023 | By Joanne S. Eglovitch
EMA official shares lessons learned from the COVID pandemic

One process that worked: For promising COVID treatments, EMA was able to provide enhanced presubmission dialogue with sponsors. EMA ...

24 March 2023 | By Joanne S. Eglovitch
Decentralized trials getting some attention on the international regulatory front

At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed s...

23 March 2023 | By Ferdous Al-Faruque
Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs

The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product sup...