Determining the right regulatory pathway for a drug product is a critical early decision that can shape the entire development strategy. While many products may appear to fit the generic model, nuances in formulation, dosage form, route of administration, or intended use can disqualify them from a traditional Abbreviated New Drug Application (ANDA). In such…
Vanessa Atayde
Alzheimer’s Disease (AD) is a progressive, irreversible brain disorder that affects memory, thinking, and language skills. Age is the best-known risk factor for AD, with symptoms usually appearing after 60 years of age. According to the Alzheimer’s Association and the Center for Diseases Control and Prevention, the number of people living with AD in the…
Epilepsy is the fourth most common neurological disorder in the world1, affecting over 68 million people globally, and approximately 2.2 million people in the US2. In pediatric populations, it is estimated that about 470,000 US children under the age of 14 have epilepsy1. However, developing anti-seizure medications for pediatric patients has long been a challenge due…