The European Medicines Agency (EMA) has published a quick guide to the rules and procedures of the Clinical Trials Regulation (CTR) alongside questions and answers on protecting commercially ...
The US Food and Drug Administration has proposed restructuring the Office of Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will ...
As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions A watershed year for biosimilars — if regulators and policymakers step up FDA device center’s 2022 report ...
The US Food and Drug Administration (FDA) has finalized a 2014 guidance that lays out its thinking what is and isn’t a ...
Many pharmaceutical companies in the EU are waiting on the sidelines to submit new clinical trial applications to the ...
Medsafe also has updated the list of what it expects sponsors to have to ensure the supply of safe and effective medicines ...
Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year 2022 in 13 different scientific areas under the Generic Drug User Fee Amendments (GDUFA ...
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not responded to surgery or are in poor health.
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The US Food and Drug Administration (FDA) proposed major changes to its blood donation policies that would make it easier for ...
After nearly three years of virtual meetings, the US Food and Drug Administration (FDA) on Monday announced it will resume scheduling in-person, face-to-face (FTF) formal meetings with drug and ...