Adverse drug events are among the leading causes of death from approved pharmaceuticals, and illnesses and deaths from these events cost the healthcare system billions of dollars each year.

As such, the Food and Drug Administration has regulations regarding the monitoring and reporting of them. Keeping track of these events is important because the full adverse drug event profile may not be known when a pharmaceutical is approved.

The consequences of failing to report adverse drug events or reporting them late are severe. The Food and Drug Administration has issued warning letters and prosecuted pharmaceutical companies that have failed to comply.

Pharmaceutical executives should understand regulations and responsibilities regarding monitoring and reporting these events.

The Guidelines Governing Adverse Drug Event Management

The guidelines that govern adverse drug event management include Title 21 Code of Federal Regulations 310.305, Title 21 Code of Federal Regulations 314.80, and Title 21 Code of Federal Regulations 314.98.

These regulations cover approved prescription medications, unapproved prescription medications and approved over-the-counter medications, and prescription medications subject to approval under abbreviated applications, respectively.

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Effective standard operating procedures are essential to organizing and managing companies big and small no matter what industry they serve.

They ensure that all personnel are conducting procedures in a standardized manner and as such, it's important to understand how to create a set of operating procedures that make genuine improvements to the way you do business.

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It is 2013, and app developers for smartphones are introducing apps almost daily that can do amazing things such as take a person’s blood pressure, measure their blood glucose, or take their pulse.

Many of these apps, known as mobile health (mHealth) applications, stem from the wants patients to monitor symptoms of their disease or of athletes to measure various parameters before, during, and following physical activity.

However, they may replace medical devices that perform the same functions.
Introducing the “First Sensible Oversight for Technology Which Advances Regulatory Efficiency” (SOFTWARE) Act.

In March of 2013, the FDA, speaking at a congressional hearing, said that it would take a “balanced approach” to mHealth.

1. The agency cited examples of items that would be free of regulation, such as sales of smartphones or tablets.

However, if an app is to replace an approved medical device, such as the blood glucometer app on the iPhone, it would be subject to the approval process. The director of the FDA's Office of Device Evaluation at the Center for Devices and Radiological Health, Christy L. Foreman, told the congressional panel,
"An inaccurate or malfunctioning mobile medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen levels in chronic lung disease patients could delay life-saving diagnosis and treatment."

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The 505(b)(2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference.

Created in 1984, it is a streamlined process and does not require the applicant to conduct all the required studies or obtain a right of reference.

A 505(b)(2) can been used to get approvals for changes such as New Delivery Mechanisms, New Dosage Forms, New Formulations and New Indications. It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being lower cost

What is the 505(b)(2)?

A 505(b)(2) is a New Drug Application that can partially rely on the FDA’s previous approvals and published literature. It is described in section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.

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