Tag Archives | FDA

An Update on the Opioid Crisis

The opioid crisis continues to loom in healthcare, as more individuals become addicted to and die from lawful and illegal forms of opioids. While controlled substances such as heroin are to blame for much of the problem, prescription medications are also a contributor. Variation in how physicians treat chronic pain and non-nerve-related back pain and […]

New Technologies Addressing Mental Health

Mental health encompasses factors such as mood swings, stress management and more serious issues like mental illness. A 2014 study by the Substance Abuse and Mental Health Services Administration found that 43.6 million Americans over age 18 experienced some type of mental illness. This isn’t a small or insignificant problem. Individuals suffering from poor mental […]

New Findings in Sarcoma

Sarcoma is a rare type of cancer, making up about 1 percent of all adult cancers and about 15 percent of pediatric cancers, according to the Liddy Shriver Sarcoma Initiative. Despite the high rate for childhood and adolescent cancers, the total number of pediatric sarcoma cases is far lower than adult cases because overall there […]

FDA’s Drug Approval Process – How it Fits into the US Health Delivery System

The U.S. Food and Drug Administration has a rigorous drug approval method, but recent years have shown that even this thorough process undergoes certain trends. Each year more new drug applications (NDA) are submitted and approved, including specialty drugs. The annual increase in the approval rates of novel and specialty drugs may signal a general […]

The Birth of Biosimilars in the US

We’ve become familiar, and even comfortable, with the concept of generic drugs. These medications are identical, or “bioequivalent,” to a brand-name pharmaceutical.   According to the U.S. Food and Drug Administration, generics must be chemically identical to and match the branded drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended […]

Medical Marijuana and Reimbursement

Medical marijuana, at one time highly doubted and hotly debated, is now a fast-growing reality. Currently 23 states and the District of Columbia provide limited legal protections from arrest for authorized patients who use cannabis with a doctor’s recommendation. Another 7 states have legislation pending.   To qualify for a medical marijuana ID card, which […]