Virtually any company involved in the manufacture of pharmaceuticals, biologics, or devices can be subject to receiving an FDA 483.
As such, pharmaceutical executives should understand the significance of receiving a Form FDA 483 and different ways of handling it.Continue Reading
Mock FDA audits are an essential tool in identifying issues that could affect the quality of manufactured pharmaceuticals or medical devices, and become compliance issues with FDA.
As such, pharmaceutical and medical device executives should understand what a mock FDA audit is, why they should arrange for a mock FDA audit to be conducted, and what a standard mock FDA audit entails.Continue Reading
To remain competitive, companies must be able to market the investigational products that they manufacture.
However, no company can market an investigational product in the United States without approval from the Food and Drug Administration (FDA). New Drug Applications (NDAs) are one of the final steps that a company takes before a drug receives approval, and an overreaching goal for pharmaceutical manufacturers is to have their NDAs approved.
The consequences of a rejected NDA, such as decreased revenue, decreases in stock prices, and allocation of additional funds and resources to rectify the issue, are severe.
Therefore, manufacturers should know what the process is, what the contents of an NDA are, and how to submit an NDA. They must also understand common issues associated with NDAs, reasons why NDAs are rejected, and ways to make the process run more smoothly.