USA – CERSI Summit: Wider use of real-world evidence continues to face hurdles
The widespread use of real-world evidence (RWE) in regulatory decisions continues to face challenges, including problems with data quality and methodologies, and a disconnect...
Europe – Actions to support the development of medicines for children
Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and...
USA – FDA issues draft guidance on mpox drug development
In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot...
USA – NIH aims to reduce reputation bias in grant reviews
The US National Institutes of Health (NIH) has released a tentative plan to change how its research grant applications are scored, with the aim of reducing...
Europe – DARWIN EU® welcomes first data partners
EMA has selected the first set of data partners to collaborate with DARWIN EU®, the Data Analysis and Real-World Interrogation Network. The data available to these...
USA – FDA issues last guidance in patient-focused drug development series
The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant...
International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation
The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...
Brazil – ANVISA approves skinny labeling in Brazil
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...
USA – FDA Says Face-to-Face Meetings Include Virtual
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled...
USA – FDA updates guidance on expanded access for investigational drugs under IND
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug...
