Tag: generic drugs

International Perspectives on NTI Generics: Regulatory Approaches Compared
International Perspectives on NTI Generics: Regulatory Approaches Compared

NTI generics require strict regulatory oversight due to their narrow safety margin. This article compares how the FDA, EMA, Health Canada, and others regulate these high-risk drugs, highlighting differences in bioequivalence standards, approval timelines, and substitution rules.

Dec 19 2025

How Insurers Decide Which Generic Drugs to Cover
How Insurers Decide Which Generic Drugs to Cover

Insurers use Pharmacy & Therapeutics committees to decide which generic drugs to cover, prioritizing safety, effectiveness, and cost. Most generics are placed in the lowest-cost tier, but coverage varies by plan - and patients can appeal denials.

Dec 15 2025

Common Pharmacist Concerns About Generic Substitution: What Really Happens Behind the Counter
Common Pharmacist Concerns About Generic Substitution: What Really Happens Behind the Counter

Pharmacists support generic substitution for cost savings, but face resistance from patients and doctors. Learn why trust, communication, and NTI drugs create real-world challenges behind the pharmacy counter.

Dec 8 2025

Therapeutic Equivalence Codes: How the FDA Determines If Generic Drugs Can Be Substituted
Therapeutic Equivalence Codes: How the FDA Determines If Generic Drugs Can Be Substituted

Therapeutic equivalence codes tell you if a generic drug can be safely swapped for a brand-name version. The FDA uses the Orange Book to assign A or B ratings based on bioequivalence, helping pharmacists make safe substitutions that save billions each year.

Nov 22 2025

Generic Manufacturing Standards: How Quality Control Stops Counterfeit Drugs
Generic Manufacturing Standards: How Quality Control Stops Counterfeit Drugs

Generic drugs are just as safe as brand-name ones - if they’re made under strict quality control. Learn how cGMP standards, digital tracking, and advanced testing stop counterfeit drugs before they reach patients.

Nov 10 2025