Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for ...
This Week at FDA: FDA names acting CBER director, House committee advances FDA budget bill, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary ...
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to ...
The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for ...
The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation ...
Recon: FDA says Replimune's pivotal melanoma study failed to show benefit; FDA guidance on peptides could affect development ...
The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS ...
AdvaMed's Zach Rothstein (left) and MDMA's Mark Leahey (right) at FDA headquarters in Silver Spring, MD. (Source: FDA) US Food and Drug Administration (FDA) officials said the next iteration of the ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top ...
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