FDA

government

Last mentioned: 2d ago

Timeline

  1. Impurity Warning

    Lilly issues formal warning after testing reveals impurities in compounded samples.

  2. Compounding Surge

    Shortage status triggers Section 503B exemptions, allowing pharmacies to mass-produce compounded versions.

  3. Zepbound Approval

    Tirzepatide approved for chronic weight management, exacerbating supply shortages.

  4. Mounjaro FDA Approval

    FDA approves tirzepatide for type 2 diabetes, leading to immediate high demand.

Stories mentioning FDA 2

Regulation Bearish

Lilly Flags Impurities in Compounded GLP-1s, Escalating Regulatory Battle

Eli Lilly has issued a formal warning regarding discovered impurities in compounded versions of its blockbuster weight-loss medication, tirzepatide. This development marks a significant escalation in the ongoing regulatory and legal conflict between pharmaceutical giants and the compounding industry over safety standards and patent enforcement.

23 sources
Regulation Neutral

Regulatory Crossroads: The Future of Direct-to-Consumer Pharma Advertising

The debate over Direct-to-Consumer (DTC) pharmaceutical advertising is intensifying as U.S. regulators face mounting pressure to align with global standards. With the U.S. remaining one of only two nations allowing the practice, new legal and ethical challenges are questioning the impact of multi-billion dollar marketing budgets on drug pricing and patient safety.

3 sources