USA – A compilation of FDA COVID-19-related guidelines

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies,...

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...

USA – FDA : Guidance Documents – Recently Issued

Recently Issued Guidance Documents...

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The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.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...
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...

France – FDA launches online forum for drug repurposing

The FDA has launched what it calls the CURE Drug Repurposing Collaboratory, an online forum for exchanging clinical practice data to identify potential new uses for existing...

USA – FDA seeks input on genotyping for pediatric codeine use

The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to...

USA – FDA gives Project Renewal update at AACR

Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress...

USA – FDA finalizes bacterial pneumonia drug development guidances

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia. Both...

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