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Click Here to Register for Free Join SAAMnow¬†for our 2023 series of webinars on 505(b)(2) NDA drug development starting April […]

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The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

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GDUFA III Commitment Letter describes FDA meeting opportunities for Generic sponsors. For instance, Product Development Meetings and Pre-Submission Meetings are designed to facilitate the completeness of the ANDA application, with the intent of decreasing the probability of receiving a CRL.

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