Category: Pharmaceutical Policy

REMS Programs Explained: How FDA Risk Evaluation and Mitigation Strategies Work

By Joe Barnett On 4 Aug, 2026 Comments (0)

Learn how FDA REMS programs work to manage high-risk drug safety. We explain ETASU requirements, implementation challenges, and future changes for patients and providers.

Authorized Generics: The Exact Brand Copy at Generic Prices

By Joe Barnett On 30 Jul, 2026 Comments (0)

Discover how authorized generics offer the exact brand-name formulation at generic prices. Learn the differences, benefits for sensitive patients, and how to access them.

Adverse Event Reporting: Pharmacist Responsibility for Generic Medication Safety

By Joe Barnett On 23 Jul, 2026 Comments (0)

Explore the critical role of pharmacists in adverse event reporting for generic medications. Learn about regulatory duties, under-reporting challenges, and practical steps to enhance patient safety.

FDA Import Inspections: How Drugs Are Monitored Entering the US in 2026

By Joe Barnett On 14 Jul, 2026 Comments (0)

Learn how the FDA monitors drug imports into the US, including inspection phases, risk factors, SSCPP benefits, and common pitfalls to avoid delays.

The Purple Book: A Complete Guide to Biosimilars and Interchangeability

By Joe Barnett On 8 Jul, 2026 Comments (0)

A complete guide to The Purple Book, the FDA's database for biosimilars and interchangeable biological products. Learn the difference between biosimilars and interchangeables, how to use the database, and the impact of state laws on substitution.

Hatch-Waxman Act Explained: How the 1984 Law Balances Brand and Generic Drugs

By Joe Barnett On 24 Jun, 2026 Comments (0)

Explore how the Hatch-Waxman Act of 1984 revolutionized US drug policy by balancing patent protections for innovators with streamlined approvals for generics, lowering costs and increasing access.

Post-market studies on generic drug safety: clinical follow-up

By Joe Barnett On 17 Jun, 2026 Comments (0)

Explore how post-market studies ensure generic drug safety through clinical follow-up, FDA surveillance, and adverse event reporting.

Tendering Systems: Europe's Approach to Generic Purchasing Explained

By Joe Barnett On 10 Jun, 2026 Comments (10)

Explore how European tendering systems impact generic purchasing. Learn about open vs restricted procedures, the MEAT evaluation method, and strategies for winning public procurement contracts in the EU.

Authorized Generics Explained: How They Differ from Brand and Traditional Generics

By Joe Barnett On 27 May, 2026 Comments (0)

Discover what authorized generics are and how they differ from brand-name and traditional generics. Learn about FDA regulations, pricing strategies, and how to identify them on your prescription.

How Brand Manufacturers Produce Their Own Generic Versions

By Joe Barnett On 7 May, 2026 Comments (0)

Discover how brand manufacturers produce authorized generics to protect profits after patent expiration. Learn about the manufacturing process, pricing strategies, and consumer impact of this pharmaceutical tactic.

Global Biosimilar Markets: Europe vs United States Comparison

By Joe Barnett On 15 Apr, 2026 Comments (10)

A detailed comparison of biosimilar markets in Europe and the US, exploring regulatory shifts, patent cliffs, and the race for healthcare cost reduction.