Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status.1 In most cases, the foreign regulatory body requires...
While COVID-19 has been the primary focus for most of us this past year, many of the health crises that were a problem before COVID-19, have, unfortunately, continued to be an issue. One of these crises is Opioid Use Disorder...
Homeopathic medicines have been around since the 1700s, and the premise behind them has not changed much in the past 300 years. The idea behind them is the premise of “like cures like”, meaning that the substance that causes a...
It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not able to afford those brand-name drugs, generic drugs are an option. Most people are somewhat familiar with the concept of...
On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA...
Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved. FDA understands that some facilities which are located in regions impacted by COVID-19 may have some travel restrictions...
The Application Programmable Interface or the API is the modern data access tool for developers. It acts like middleware or a software intermediary that allows two applications to talk to each other in terms of data. Data is an important...
Computational Intelligence (CI) is one of the major pillars of Artificial Intelligence. It is the study, design, and development of intelligent software based on the theory of evolution. Within the past decade, healthcare has become expensive. Also, with the declining...
Currently, we live in a world driven by the 4th Industrial Revolution in which science and technology are continuously evolving. But what exactly is Industry 4.0? It is the process of using tech platforms like Cloud, IoT, AI, and Analytics...