Europe – Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
The aim of this guideline is to describe the expected content of physiologically based pharmacokinetic (PBPK) modelling and simulation reports included in regulatory submissions, such as applications for...
USA – COVID-19 guidelines updated to include steroids
The Infectious Diseases Society of America (IDSA) has updated its treatment guidelines to include generic steroid pills for patients hospitalized with severe COVID-19, the...
USA – Guidance : Development and Licensure of Vaccines to Prevent COVID-19
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic...
International – EMA and Korean Ministry of Food and Drug Safety to share confidential...
EMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have signed an agreement that allows them to share confidential information...
USA – FDA : Guidance Documents – Recently Issued
Recently Issued Guidance Documents...
International – WHO ACT-Accelerator prioritizes global vaccine approach
The importance of a global approach to vaccine development and production, with a focus on collaboration, was a topic of a technical update and...
USA – Guidance : Pediatric anti-infective development addressed by FDA
The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.
The...
Europe – Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
Overview of comments received on 'Points to...
USA – Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance
This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders...
Europe – Eight medicines leap towards EU approval
As PharmaTimes previously reported, Gilead's Veklury (remdesivir) has been recommended for conditional approval for treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia...
