Category: Pharmaceutical Policy

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

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

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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.

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

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

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

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Tendering Systems: Europe's Approach to Generic Purchasing Explained

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

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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.

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

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

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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.

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How Brand Manufacturers Produce Their Own Generic Versions

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

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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.

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Global Biosimilar Markets: Europe vs United States Comparison

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

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

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Generic Drug Shortages: The Paradox of Competition and Supply

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

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Explore the paradox of generic drug shortages: why more competition can actually lead to fewer manufacturers and unstable medical supplies.

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Regulatory Exclusivity Explained: Non-Patent Market Protections in Pharma

By Joe Barnett    On 26 Mar, 2026    Comments (8)

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Regulatory exclusivity acts as a market protection tool separate from patents, blocking generic competition for specific periods. Learn how FDA rules shape drug pricing and availability.

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