Labeling

Regulatory Sciences

Leveraging Online FDA Information to Accelerate ANDA Timelines

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

FDA Drug Labeling Requirements & Regulations: What’s in Your Label?

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

6 Compliance Tips to get FDA Approval for Your Pharmaceutical Project

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

#2: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

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...