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FDA Authorization of Generics: Legal Basis and Approval Process Explained

FDA Authorization of Generics: Legal Basis and Approval Process Explained

Learn how the FDA approves generic drugs under the Hatch-Waxman Act, the science behind bioequivalence, and why generics are safe, affordable, and critical to U.S. healthcare.

Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

The Hatch-Waxman Act of 1984 created the legal framework that made generic drugs possible in the U.S., balancing innovation incentives with affordable access. Today, 90% of prescriptions are filled with generics thanks to this landmark law.

St. John’s Wort and SSRIs: The Hidden Danger of Serotonin Syndrome

St. John’s Wort and SSRIs: The Hidden Danger of Serotonin Syndrome

Combining St. John’s Wort with SSRIs can trigger serotonin syndrome-a life-threatening condition. Despite being sold as a natural remedy, this herb dangerously boosts serotonin levels and interferes with common antidepressants. Experts warn against any use together.

Generic Drug Interactions: How Digital Consultation Tools Keep You Safe

Generic Drug Interactions: How Digital Consultation Tools Keep You Safe

Digital consultation tools help prevent dangerous interactions between generic drugs, supplements, and prescriptions. Learn which apps work best, how to use them, and why they're essential for medication safety.

Rifampin and Birth Control: What You Need to Know About Contraceptive Failure Risks

Rifampin and Birth Control: What You Need to Know About Contraceptive Failure Risks

Rifampin can make birth control pills, patches, and rings fail by speeding up hormone breakdown. This is the only antibiotic proven to cause contraceptive failure. Learn what backup methods actually work and how long you need to use them.

How to Check If a Generic Medication Is Available for Your Prescription

How to Check If a Generic Medication Is Available for Your Prescription

Learn how to check if a generic medication is available for your prescription and save up to 90% on drug costs. Find out how to use the FDA's Orange Book, talk to your pharmacist, and avoid common pitfalls.

Tentative Approval and Litigation: Navigating the Path to Generic Drug Market Entry

Tentative Approval and Litigation: Navigating the Path to Generic Drug Market Entry

Tentative approval from the FDA lets generic drug makers prepare for market entry while patents are still active. But missing deadlines or mismanaging litigation can cost millions. Here’s how to navigate the system and avoid costly delays.

Serious Adverse Events: Reporting Procedures for Generic Drugs

Serious Adverse Events: Reporting Procedures for Generic Drugs

Despite identical FDA regulations, serious adverse events from generic drugs are severely underreported. Learn why this gap exists, how to report correctly, and what’s being done to fix it.

How Generic Medications Save Thousands on Healthcare Costs

How Generic Medications Save Thousands on Healthcare Costs

Generic medications save Americans billions each year by offering the same effectiveness as brand-name drugs at a fraction of the cost. Learn how generics work, how much you can save, and what to ask your doctor or pharmacist.

Generic Drug Approval Standards: Safety, Quality, and Strength Requirements

Generic Drug Approval Standards: Safety, Quality, and Strength Requirements

Generic drugs must meet the same safety, strength, quality, and bioequivalence standards as brand-name drugs under FDA oversight. Learn how the ANDA process ensures generics are just as effective-and why complex formulations take longer to approve.