Drug-device Archives - Lachman Consultant Services, Inc.

Close-up medical syringe with a vaccine.

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

By Bob Pollock Oct 12, 2023 ANDAs Combination Products Device Drug-device OGD Regulatory Affairs

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 […]

Apr

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

By Bob Pollock Apr 27, 2022 Combination Products Drug-device FDA

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 […]

Drug-device

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

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

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