EMA Management Board – highlights of March 2020 meeting

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...
WHO drafts guidance for pharma supply chain tracking

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The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.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...
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery

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...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

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...

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