Close-up medical syringe with a vaccine.

Drug-Device Combinations for Generic Drugs: A Good Session at AAM’s GRx+Biosims Conference

Remember the good old days, when a dosing spoon or cup was dispensed with liquid medication and a product in a prefilled syringe was just a drug?  Well, we know now that those days are over, and maybe they should be.  The presentation by three FDAers, Markham Luke, MD, PhD, Karyn L. Berry, MD, MPH, and […]

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Complex Products – What Does OGD Look at When Evaluating Comparability?

At the Generic Drug Forum virtual SBIA event that is still ongoing, Andrew J. Fine, PharmD, BCPS, Senior Advisor, Division of Clinical Review, Office of Safety & Clinical Evaluation, Office of Generic Drugs, provided a look at the type of information that needs to accompany a complex product (particularly a drug device combination) to establish […]

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