The FDA’s Adverse Event Reporting Requirements

The adverse event reporting system is an important highlight of the FDA’s adverse event reporting requirements. This is the mechanism through which adverse event reporting requirements are listed out for the FDA to take further action. The adverse event reporting system may be understood as being a database that aids and supplements the FDA’s postmarketing […]

Internal Audit Checklist for HIPAA

The internal audit checklist for HIPAA is one of the primary elements of HIPAA implementation. The passage of the Health Insurance Portability and Accountability Act (HIPAA) by the U.S. Congress in 1996 was aimed at regulating the way and process by which healthcare institutions across the country reveal the medical information of their patients. The […]

It is important for non-statisticians to become familiar with biostatistics

Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application […]

The ISO 13485: 2016

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003. […]

Testing GxP system that is FDA-compliant

Process validation is the method of using data from stages ranging from the process design stage to production, to ensure that the process that is being used can deliver consistently high-quality products. Companies that come under the life sciences must comply with GxP regulations to ensure that their processes meet the regulatory guidelines to be […]

Understanding the infinite area of medical device compliance

With a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic. With the FDA being the sole regulator for this very vast area; it comes up with regulations, […]

Project Management is important for non-Project Managers, too

A few skills need to be imbibed by professionals, even if they are out of their domains or area of expertise. This is because when it comes to handling crunch situations; one cannot expect a manager to throw up his arms and say that nothing can be done. Just some knowledge of the work could […]

GMP and Regulatory Expectations for Early IND Products

 What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. These new guidelines appear to […]

Video of father comforting newborn son receiving his first vaccines goes viral

On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, […]

Putting an effective complaint and recall management system in place

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all […]