Tag: Regulatory affairs

In the United States, Aniracetam is not classified as a federally controlled substance like many illicit drugs, but its classification as an "unapproved new drug" by the Food and Drug Administration (FDA) is the key reason for the often-asked question: *Why is aniracetam illegal*?. This regulatory nuance makes its sale and marketing as a dietary supplement or medication unlawful for human consumption.

With high rates of drug candidate attrition in clinical development, a thorough understanding of **what is characterization of a drug?** is paramount for ensuring a successful and safe final product. This comprehensive analysis of a drug's properties is a cornerstone of pharmaceutical science, underpinning the entire lifecycle of a medication from discovery to market.

According to trade association PhRMA, developing a new pharmaceutical from discovery to regulatory approval takes an average of 10 to 15 years and can cost billions of dollars. Understanding what is bringing a new drug to market reveals a multifaceted process involving scientific innovation, extensive testing, and strict regulatory oversight.

In 2022, over 1.25 million serious adverse drug events were reported to the FDA, including nearly 175,000 deaths. This highlights the critical need for pharmacovigilance, the science devoted to monitoring, detecting, and preventing adverse effects of medicines to ensure patient safety.

In the complex and jargon-filled pharmaceutical industry, the acronym DSI can refer to at least five different concepts, from drug safety to digital genomics. Understanding **what is DSI in pharmaceutical?** is crucial for navigating specific sectors like drug development, regulatory affairs, or digital health.

Regulatory bodies like the FDA issue hundreds of warning letters annually for non-compliance, with significant financial penalties. Understanding **what GxP in pharma is** becomes crucial, as it represents the set of guidelines that ensures pharmaceutical products are safe and effective.

The global pharmaceutical market is projected to reach over $1.7 trillion by the end of 2025, fueling significant career opportunities [1.8.2]. When considering a career path, it's crucial to ask: **which department is best in the pharma industry** for long-term success and satisfaction?