Keeping current with constantly changing regulations can be challenging. In some cases, pharmaceutical companies may find that their practices are not compliant with current guidelines and that remediation measures are necessary.
As such, pharmaceutical companies should understand how to develop effective remediation projects.Continue Reading
Recent changes to the Food and Drug Administration Modernization Act of 1997 have facilitated the review and approval of novel devices. The process of classification of the de novo mechanism is one such change.
As such, device manufacturers should understand what a de novo classification is, the circumstances under which its use is appropriate, and scenarios under which device manufacturers can obtain a de novo classification.
The FDA Group Ranks No. 294 on the 2015 Inc. 500|5000 List with Three-Year Sales Growth of 1,552%Continue Reading
One of the challenges that device manufacturers face is determining how to proceed when developing a device. The issue becomes more complicated for devices that do not fit into one definite class.
As such, the Food and Drug Administration has established a mechanism in Section 513(g) of the Federal Food, Drug, and Cosmetic Act by which device manufacturers can obtain answers regarding how FDA would classify their device, thus determining the approval process. As such, understanding how to use the mechanism is important to device manufacturers.Continue Reading
Human factor studies are an integral part of any device or drug delivery system submission. The Food and Drug Administration requires them to fulfill the requirements for device safety.
As such, pharmaceutical and medical device executives should understand what human factor studies are, what regulations govern human factor studies, what factors to consider when designing human factor studies, and how to conduct human factor studies.Continue Reading
Determining whether the sales of a pharmaceutical product can offset the cost of developing it is an important factor to consider when deciding whether to develop a pharmaceutical product. This is particularly true for products used to treat rare conditions in which the costs of developing the product are too great to offset any revenue gained through sales.
In order to encourage pharmaceutical companies to develop treatments for rare conditions, the Food and Drug Administration passed the Orphan Drug Act of 1983. This legislation provides incentives for pharmaceutical companies to develop products to treat rare conditions.
Since the legislation has been enacted, the number of orphan drug approvals has increased. In 2014, approximately thirty-six orphan drugs were approved. Therefore, pharmaceutical executives should understand how to take advantage of this growing market.Continue Reading