The ANDA process is the legal pathway for generic drug approval in the U.S., governed by the Hatch-Waxman Act. It requires bioequivalence, identical formulation, and strict manufacturing standards to ensure safe, affordable alternatives to brand-name drugs.
The FDA's 2023-2025 updates to generic drug approvals prioritize U.S.-made medications to fix supply chain gaps. Learn how the new pilot program affects drug availability, pricing, and manufacturing.
Dependence on foreign manufacturing for pharmaceuticals is causing widespread drug shortages. Learn how China and India supply most of the world's active ingredients-and why diversifying supply chains is critical for patient safety.
Evergreening lets pharmaceutical companies extend drug monopolies with minor changes, blocking cheaper generics and keeping prices high. Learn how it works and why it hurts patients.
Generic drugs save the U.S. over $330 billion a year, but brand manufacturers face massive revenue losses when patents expire. Learn how patent cliffs, pay-for-delay deals, and PBM pricing distortions shape the real cost of medicine.
Benzodiazepines like Xanax and Valium are still prescribed to seniors despite proven risks of falls, dementia, and dependence. Learn why experts say they're unsafe and what safer, effective alternatives exist for anxiety and insomnia in older adults.
Healthcare staffing shortages are worsening, leading to longer waits, medical errors, and closed clinics. Hospitals and clinics are struggling to keep up as nurses and doctors leave the field faster than they're replaced.
Accurate dosing of liquid medications is critical to avoid underdosing or overdosing. Oral syringes marked in milliliters are the most reliable tool, especially for children. Avoid kitchen spoons and confusing dosing cups.
Federal actions in 2025-2026 aim to combat record drug shortages through API stockpiling, AI forecasting, and second-source manufacturing-but gaps in funding, reporting, and economic incentives still leave patients at risk.
Clinical studies show generic medications work as well as brand names for most people-but not all. For epilepsy, heart, and blood-thinning drugs, switching can carry risks. Here’s what the data really says.