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Tag: FDA regulations

Bioequivalence Waivers: When the FDA Skips In-Vivo Studies

Bioequivalence Waivers: When the FDA Skips In-Vivo Studies

  • May 5, 2026
  • Kiera Masterson

Discover when the FDA allows bioequivalence waivers, skipping costly human trials for generic drugs. Learn about BCS Class I and III eligibility, dissolution testing requirements, and the financial benefits of biowaivers.

False Advertising in Generics: Legal Risks and Rules You Can't Ignore

False Advertising in Generics: Legal Risks and Rules You Can't Ignore

  • December 27, 2025
  • Kiera Masterson

False advertising in generic drugs misleads patients, harms competition, and violates federal law. Learn the legal risks, FDA rules, and what claims are allowed-or banned-in 2025.

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