Tag: generic drugs

Learn how the FDA uses FAERS, the Sentinel Initiative, and factory inspections to ensure generic drugs remain safe and effective after they hit the market.

Generic drug manufacturers face collapsing margins due to price wars and rising costs. Discover how companies are shifting from commodity production to complex generics and contract manufacturing to survive - and keep essential medicines available.

Cmax and AUC are the two key pharmacokinetic measures used to prove generic drugs work like brand-name versions. Cmax shows peak concentration, AUC shows total exposure-both must fall within 80%-125% for approval.

Doctors prescribe generics for 90% of medications, but many lack training on bioequivalence. Learn why knowledge gaps persist, how real-world feedback changes prescribing, and what's being done to fix it.

Authorized generics are identical to brand-name drugs but sold under a different label. As of 2026, only a handful are available due to FTC crackdowns and market shifts. Learn which ones are still on the market and how to identify them.

Modified-release formulations require special bioequivalence testing to ensure generics work as safely and effectively as brand-name drugs. Learn the key regulatory requirements, common pitfalls, and why standard tests aren't enough.