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Tag: Regulatory action

Explore our medication guides and pharmacology articles within this category.

The Truth Behind Why Were Monoclonal Antibodies Banned for Some Uses

4 min read
Between 2021 and 2023, the U.S. Food and Drug Administration (FDA) revoked Emergency Use Authorizations for several specific COVID-19 treatments. While this led to public questions asking why were monoclonal antibodies banned, the reality is more nuanced, involving a complex interplay of viral evolution, therapeutic effectiveness, and evolving safety data.

What drug did the FDA say was ineffective?: The Case of Oral Phenylephrine

5 min read
In September 2023, a U.S. Food and Drug Administration (FDA) advisory committee unanimously declared oral phenylephrine, a common active ingredient in over-the-counter decongestants, ineffective. This decision, which has led the FDA to propose removing the ingredient's market status, reveals a decades-old issue with a drug many consumers assumed was working. The situation raises an important question: **what drug did the FDA say was ineffective**?