Category: Legal Framework

Pharmacy Reimbursement Models: How Laws Shape Generic Drug Payments

Pharmacy Reimbursement Models: How Laws Shape Generic Drug Payments

How federal and state laws shape generic drug payments through MAC pricing, Medicare Part D, PBMs, and substitution rules-and what patients and pharmacists can do about it.

EMA vs FDA Drug Labeling: Key International Differences That Impact Patients and Pharmacies

EMA vs FDA Drug Labeling: Key International Differences That Impact Patients and Pharmacies

The EMA and FDA approve the same drugs but with vastly different labeling rules. These differences affect how doctors prescribe, how patients understand risks, and why the same medicine has different instructions across borders.

Orphan Drug Exclusivity: How Rare-Disease Medicines Get Market Protection

Orphan Drug Exclusivity: How Rare-Disease Medicines Get Market Protection

Orphan drug exclusivity gives pharmaceutical companies seven years of market protection for rare-disease treatments, driving innovation where profits were once impossible. Here's how it works, who benefits, and why it's under scrutiny.

False Advertising in Generic Drugs: Legal Risks and What You Must Know

False Advertising in Generic Drugs: Legal Risks and What You Must Know

False advertising in generic drugs misleads patients into thinking generics are unsafe or less effective. Learn the legal risks, FDA rules, and how to spot deceptive ads that could harm your health.

Liability and Indemnification in Generic Transactions: What You Need to Know

Liability and Indemnification in Generic Transactions: What You Need to Know

Indemnification in commercial transactions shifts financial risk from one party to another. Learn how liability clauses work, what to include in contracts, and how to avoid common legal traps.