COVID-19 vaccine initiatives OWS: Operation Warp Speed is a collaboration of several US government departments including Health and Human Services (HHS) and subagencies, Defense, Agriculture, Energy ...
This article provides a comprehensive overview of recent changes in US trade policy. It highlights key developments such as new global tariffs and bilateral trade agreements, sector- and ...
Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific ...
The US Food and Drug Administration (FDA) has released a new final guidance on preparing a pre-request for designation (Pre-RFD) with the Office of Combination Products (OCP), that contains ...
It can be challenging to ensure standard language is used when writing regulatory and medical documents, especially when every agency and customer has their own rules. This session explores how to ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
This article discusses the regulatory classification of novel foods, providing guidance for companies on the procedures that apply to novel foods and ingredients in the EU and internationally. It ...
A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to ...
The US Food and Drug Administration’s (FDA) office responsible for approving cancer therapies has been renamed the Office of Oncologic Diseases (OOD) and restructured to add new divisions, the agency ...
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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