FDA Enforcement Activities: Inspections, Warning Letters, and Import Alerts
The Food and Drug Administration (FDA) is responsible for ensuring that products under its jurisdiction,…
Types of Market Exclusivities and Implications on Forfeiture
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors:…
Comprehensive Guide to Reference Standards and Materials in Pharmaceuticals
In the world of pharmaceutical development, reference standards and materials play a critical role in…
Residual Solvents: Basics, Importance, and Assessment
The solvents are organic and volatile in nature that are evaporated during the processing steps.…
Intellectual Property Rights (IPR) in the Pharmaceutical Industry: A Comprehensive Review
Intellectual Property Rights (IPR) play a crucial role in fostering innovation and protecting the work…