What makes teams successful, based upon a study of employees working within process improvement teams for each of six large corporations, led to a list of approaches for achieving organizational quality, albeit one improvement project at a time. When I parsed these lists together with a focus upon leadership to achieve organizational quality, I was able to place the key concepts into the seven categories listed below.
Coronavirus (COVID-19) has been prevalent in the United States for over 2 years, on July 6th, the Food and Drug Administration (FDA) modified the Emergency Use Authorization (EUA) for Paxlovid for COVID-19 treatment. Paxlovid is a co-packaged, nirmatrelvir tablet and ritonavir tablet for oral use to assist with the treatment of COVID-19 in adult and pediatric patients with positive SARS-CoV-2 testing1. The nirmatrelvir inhibits the SARS-Cov-2 protein to stop the virus whereas the ritonavir slows down the breakdown of nirmatrelvir to help it remain in the body for a longer period.
If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs are exactly what they sound like – an annual review of your drug product based on product batch and product yield, customer complaints, recalls, stability data, and validation data just to name a few. ADPRs should be performed in order to maintain compliance with 21 CFR 211.180 and to be in alignment with the FDA’s Guidance for Industry, Q7A GMP for Active Pharmaceutical Ingredients.
When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public.
A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Tears in the anterior cruciate ligament (ACL) are one of the most common sports injuries every year. Despite being...
The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn...