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Recent Blog Posts

Is My Product a Medical Device?

Is My Product a Medical Device?

A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’. Intended Use and Indications...

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FDA Withdraws 216 ANDAs

FDA Withdraws 216 ANDAs

Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4...

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