Category: Regulatory affairs

Over 90% of all solid-dose drugs on the market today use microcrystalline cellulose (MCC) as a binding agent. While its widespread use might suggest a direct approval, the regulatory path for a substance like microcrystalline cellulose is different from that of an active drug and depends on its specific application.

First approved by the FDA on February 1, 1965, Kenalog-40 is a corticosteroid used for many inflammatory conditions. Contrary to some beliefs, the answer to 'Is Kenalog banned in the United States?' is no; it is an FDA-approved, prescription medication.

In January 2023, the U.S. Food and Drug Administration (FDA) initially rejected Eli Lilly's application for accelerated approval of its Alzheimer's drug, donanemab, citing a limited number of patients with adequate long-term data. This was not the only regulatory hurdle the treatment would face, as the European Medicines Agency (EMA) also refused authorization later due to an unfavorable risk-benefit assessment.

In late 2024, the FDA's advisory committee delivered an 11-3 vote against approving sotagliflozin (brand name Zynquista) for type 1 diabetes patients with chronic kidney disease. This decision marked the second major setback for the drug in this indication, as the FDA rejected sotagliflozin once again over persistent and unmitigated concerns about a heightened risk of diabetic ketoacidosis (DKA).

According to the National Institutes of Health (NIH), a valid Individual Case Safety Report (ICSR) must contain four minimum criteria to be reportable to regulatory bodies. This critical component of pharmacovigilance is designed to monitor drug safety by identifying and reporting adverse drug reactions and is centered around understanding what are the 4 elements of ICSR.

The PBRER submission schedule is not a single, fixed timeline but varies based on factors like a drug's lifecycle, with new products requiring more frequent reports initially before transitioning to less frequent intervals. This variable reporting frequency is a cornerstone of modern pharmacovigilance and directly addresses the question of **How often is PBRer submitted?**.

In the European Union, no medicinal product can be released for sale without a Qualified Person's certification. So, who is a qualified person for Directive 2001 83 EC, and what stringent criteria must they meet to uphold public health standards and ensure pharmaceutical quality?

The United States Prescribing Information (USPI) serves a similar function to the EU's Summary of Product Characteristics (SmPC), providing vital drug information for healthcare professionals. While both documents detail a drug's approved usage, safety, and effectiveness, significant differences in format, content, and regulatory oversight mean they are not identical. This article clarifies what is the US equivalent of SmPC and explores the distinctions that affect prescribers and manufacturers alike.

In July 2012, new EU pharmacovigilance legislation was implemented, triggering the replacement of EudraLex Volume 9A with the comprehensive Good Pharmacovigilance Practices (GVP) guidelines. This significant shift in medication safety and pharmacovigilance marked an evolution in regulatory standards for the pharmaceutical industry across Europe.

According to the FDA, the journey of a new drug from discovery to market can take over a decade and cost billions of dollars. This extensive process is defined by a series of rigorous stages designed to test for both safety and effectiveness. Understanding what are the 5 steps for FDA approval sheds light on the high standards required for new medications.