In the healthcare supply chain world, the year 2020 created a notable split. Even those not directly involved in the healthcare industry, that would otherwise have no vested interest in healthcare-specific supply chain knowledge, felt the...
The United States Food and Drug Administration (FDA) estimates that more than 30 million people living in the U.S. are affected by over 7,000 rare diseases. Many of these rare diseases do not have a known...
Your success as a pharmaceutical company heavily relies on the implementation of a quality management system. With ever-changing FDA regulations and technological advancements, the demand for solid infrastructure with quality in mind is increasing. Truthfully, the...
The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, which aims to create a uniform national licensing standard for wholesale distributors and third-party logistics providers (3PLs). Historically, states have set their...
There are a variety of challenges that patients may face when accessing medication. In fact, a 2019 study on medication access identified 17 distinct barriers that patients must overcome, including costs, transportation, and geographical characteristics...
With all the challenges facing the global supply chain in recent years, including materials and labor shortages, it comes as no surprise that third-party logistics (3PL) providers are looking to utilize cutting edge technologies to create...
The healthcare industry is one of the most highly regulated out there — and for good reason. When it comes to developing and then getting life-saving medications to patients, there is little room for error. Regardless...
Over the past 5 years, the FDA has approved an average of 51 novel drugs annually. As a manufacturer prepares to bring any new drug to market, there are several important decisions to be made...
To most people, the medical supply chain probably doesn’t seem overly complicated. If they ever take the time to think about it, they likely come up with four general categories which are involved in the process:...
What is an FDA Inspection? Whether you manufacture, handle, transport, or store drugs, there are a host of quality and regulatory requirements which must be followed to ensure you are in federal and state compliance. One of...
