FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging Packaging 59

Pharmacy Checkers

FEBRUARY 14, 2020

Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. Below are U.S.

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. However, many individuals still harbor misconceptions and doubts about the efficacy and safety of generic alternatives. What Are Generic Drugs?

Generic Drugs 89

Generic Drugs Drugs Branding Bioequivalency 89

Drug Patent Watch

FEBRUARY 17, 2025

Unlocking the Path to Affordable Medications: A Step-by-Step Guide to Generic Drug Approval As a healthcare professional or a patient advocate, you're likely no stranger to the importance of affordable medications. But have you ever wondered what it takes for a generic drug to hit the market?

Generic Drugs 52

Generic Drugs Bioequivalency Drugs Branding 52