Pharmaceutical companies have a renewed interest in developing small-molecule compounds in recent years.

Small molecules have shown promise in fighting cancer, polyomaviruses, and major depressive disorder.

Therefore, pharmaceutical executives should understand common issues that can occur during the development process.

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Application of risk management to devices can be challenging, especially when standards can change.

However, because risk management occurs for the entire life cycle of a device, understanding the steps involved and applying them appropriately is important.

General Considerations of ISO 14971

ISO 14971 is an international standard that applies to the risk management of medical devices.

It provides a means for a manufacturer to analyze, evaluate, control, and monitor risks to patients, operators, other equipment, and the environment. However, it does not require a device to be entirely risk-free or set a specific level of acceptance of risk.

Manufacturers and other stakeholders should realize that no medical device can be entirely risk-free. Each entity involved can place a different value on the possibility of harm occurring and the seriousness of the harm. As such, risk management can be complex.

However, the probability that harm will occur and the consequences of that harm both affect the concept of risk.

In general, the steps include establishing a risk management framework, performing a risk analysis, and documenting the results. These steps also consist of several smaller steps to ensure compliance.

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As patents for older biologicals expire, a new market for biosimilars has opened.

This new market allows manufacturers to market less expensive alternatives for patients. Despite this, the Food and Drug Administration (FDA) had done little to establish a mechanism for biosimilar approval until relatively recently, and only a few biosimilars have been approved in the United States to date.

However, with the recent guidances that the FDA has issued on biosimilars, it is important for executives to understand the process.

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As a process by which the Food and Drug Administration grants approval to Class III devices, the premarket approval mechanism is the most rigorous type of approval the agency has.

As such, manufacturers of these devices should understand the process.

The Steps in a Premarket Approval

The premarket approval process occurs in four steps. The first step is a limited scientific review to determine completeness.

If the application is filed, the appropriate personnel will conduct an in-depth review of the scientific, regulatory, and quality systems. Then an advisory panel will review the submission and provide recommendations. The agency will then deliberate and provide a decision.

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