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25 September 2020
The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a 24 July 2020 executive order issued by President Donald Trump that directed t...

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25 September 2020
More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.
25 September 2020
A new consensus statement, dubbed the CONSORT-AI extension, lays out the rules of the road for clinical trial reports on interventions involving artificial intelligence (AI). The statement calls on researchers who report on trials that include AI ...
25 September 2020
This update includes new entries for PB1046 and galidesivir and updates on dexamethasone, Actemra and convalescent plasma.
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20 September 2020
Collaborating with FDA can accelerate time to approval. Understand the purpose and timing of Type A, Type B, and Type C Meetings with FDA.
24 September 2020
The European Medicines Agency (EMA) has issued a new guidelines on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.
24 September 2020
The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.