USA – Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those...

USA – US FDA launches pilot program for RFD and Pre-RFD electronic submissions process

The US FDA’s Office of Combination Products (OCP) announced a pilot program in the Federal Register to help the OCP evaluate a potential new electronic submissions process for...

USA – LPAD pathway: FDA finalizes guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic...

USA – FDA provides guidance on preparation and submission of pediatric study plans

In a final guidance document, the US Food and Drug Administration provides sponsors with a detailed framework for how to prepare and submit pediatric...

Canada – The Canadian application process and alternate pathway for COVID-19‒related clinical trials

This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of...

USA – US secures 100M doses of Sanofi-GSK COVID-19 vaccine

Sanofi and GlaxoSmithKline will receive up to $2.1 billion from the U.S. government to further develop their coronavirus vaccine and provide Americans with 100...

USA – FDA Purple Book Database now includes all CBER-, CDER-licensed biological products

The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for...

USA – FDA Approves New Indication for Drug Containing an Active Ingredient Derived from...

Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC)...

USA – Glycolic acid, TCA among proposed additions to 503B bulk drugs list

Four new bulk substances are up for inclusion on the list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under...

USA – FDA issues new unit-dose repackaging guidance

Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions,...

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