Category: Regulatory affairs

Enacted on November 6, 2001, Directive 2001/83/EC consolidated three decades of pharmaceutical legislation into the single, foundational European Union law regulating medicinal products for human use. This directive ensures high standards of safety and quality for all medications sold within the EU's internal market.

The U.S. Food and Drug Administration (FDA) has over 20,000 prescription drug products approved for marketing [1.2.2]. This figure, however, only scratches the surface when answering: **How many products are currently approved by the FDA?** The agency's oversight is vast, covering everything from complex medical devices to biologics.

While more than 90% of new drugs fail during clinical trials, the rate of denial at the final application stage is more nuanced [1.6.6]. An analysis of applications from 2000-2012 found that while 50% failed on the first cycle, 73.5% were ultimately approved [1.6.7].

Between 1953 and 2013, 462 medications were withdrawn worldwide, primarily due to adverse reactions [1.9.4]. Understanding what drugs are discontinued involves looking at safety, efficacy, and commercial factors that lead to their removal from the market.

The FDA's Orange Book is updated on a multi-tiered schedule, with certain information being updated daily, while other components are updated monthly, quarterly, or annually. This staggered system ensures that stakeholders in the pharmaceutical industry and the public can access the most current information regarding approved drug products and therapeutic equivalence evaluations.

Over 7,500 organizations use MedDRA, and thousands more rely on WHODrug, highlighting the widespread need for standardized medical and drug terminology. While both are essential tools in clinical research and pharmacovigilance, knowing what is the difference between MedDRA and Whodrug is crucial, as they serve entirely different, yet complementary, functions.

While major depressive disorder affects millions in Europe, the antidepressant Pristiq is notably absent from the EU-wide market. Contrary to common belief, the answer to 'Why is Pristiq banned in Europe?' is that it isn't—its market application was voluntarily withdrawn by the manufacturer [1.4.1].

Did you know that in the U.S., the authority to determine drug classifications for controlled substances is shared between the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA)? This complex process, which involves assessing potential for abuse, medical utility, and dependence, is essential for regulating access to medications and preventing misuse.

As of March 2024, there were over 220,000 domestic and foreign food companies registered with the U.S. Food and Drug Administration (FDA) [1.6.2]. Verifying a company's status is a critical step for due diligence, and knowing **how do I find out if a company is registered with the FDA?** involves using specific government databases that vary by industry.

According to the FDA, a Drug Master File (DMF) is a confidential submission providing detailed information about a drug's manufacturing, processing, or packaging. Its primary purpose is to safeguard a company's confidential proprietary information while providing regulatory agencies with necessary data for drug application evaluation.