Regulatory

On April 2nd, 2021, the FDA provided an update on its Pandemic Preparedness and Recovery Plan (PREPP) Initiative. The initiative evaluated FDA’s response to the pandemic by an independent third-party reviewing agency that published a summary report outlining recommendations for...

Breaking news hit early this week regarding potential problems with Johnson & Johnson’s one-shot COVID vaccine, causing the FDA and the CDC to recommend pausing the administration of the vaccine until further investigation can be completed. On top of canceled...

Human Factors Engineering is a major component of the Design Controls process for Medical Devices. Understanding how the users of your medical device will interpret the training and instructions for your product is just as important as making sure your...

Following the US FDA and now the EU Commission’s EUDAMED, Australia’s Therapeutic Goods Administration (TGA) also has announced the introduction of the unique device identification database for medical devices marketed in Australia. The announcement first came on October 6th, 2020 that...

The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated products. The accreditation is granted to third parties based on certain eligibility criteria and training. Manufacturers...

Public health is generally defined as the health of the population as a whole. The World Health Organization gives a more detailed definition as “the art and science of preventing disease, prolonging life, and promoting health through the organized efforts...

As we face the most challenging public health crises of our lifetimes, celebrating and thanking all those who serve public health each day is more important than ever. The American Public Health Association celebrates the week of April 5th- April...

Cell therapies are regulated as biologics under the Center for Biologics Evaluation and Research division of the FDA. All somatic cell therapies are regulated as biologics, however, some of the human cell therapy products are not considered biologics because of...

The FDA’s adverse event reporting system (FAERS) is a web-based tool that allows users to interactively search and query adverse event data. The tool intends to provide users access to adverse event reports submitted by the pharmaceutical industry, health care...

Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has recently pushed for an increase in using RWE to support regulatory submissions, in an effort to promote public health. To define what...