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Could a company with a good idea for a drug name "reserve" that name, preventing another company from using it or using another name similar enough to it to create confusion? While the idea has long been advanced by those in industry, the US Food and Drug Administration (FDA) now says it's willing to consider the idea as well, and is soliciting public input on the proposal.
The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how regulators will evaluate applications in order to determine "substantial equivalence."
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.