Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated ...
The US Food and Drug Administration (FDA) is seeking feedback on a competency-based approach to regulating medical devices ...
The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.
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 Wednesday finalized guidance addressing frequently asked questions related to ...
The European Medicines Agency (EMA) is running a consultation into plans to streamline the nonclinical development of treatments for severely debilitating or life-threatening diseases. EMA outlined ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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 ...
Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2027 needs to bring in $58,926,749 before being adjusted ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
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