On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
Drug product labeling is the primary communication tool for any drug product.
Therefore, package insert needs to be current, complete, comprehensive, correct, and consistent. If you are waiting for a case series of adverse events, FDA safety alert, or Phase IV results before changes will be considered, read this paper.
If your drug product’s labeling has become static, you still have pregnancy categories, or Pre-PLR labeling, or your reference section hasn’t been reviewed in the last year, you probably have work to do.
To learn more about why you should consider these and other less obvious reasons for a review of your current labeling click here to download ‘When to Change Drug Labeling?’ and feel free to contact PDG.
PDG is here to help whether the change requires a prior approval supplement (PAS), changes being effected (CBE), CBE-30, or annual report notation.
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...