Regulatory Sciences
In the race to generic drug approval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities,...
Regulatory Sciences
Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...
Regulatory Sciences
FDA Approval Process Overview The Food and Drug Administration (FDA), as part of the United States (US) Department of Health and Human Services, is the regulatory agency responsible for the review,...
Regulatory Sciences
In 2013, the FDA released a guidance entitled "Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements." This guidance was finalized after...