FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks and benefits that go into the clinical trial, and errors need to be identified and corrected at this stage. Wrong data could lead to disastrous consequences for the study, the subjects that are part of it, the organization and eventually, patients.

Basic nature of FDA requirements for premarketing clinical trial safety

The FDA has a set of requirements for premarketing clinical trial safety, but these are mostly informal and loose. They are more of an advisory nature than being stringent regulatory requirements that are legally enforceable. Most FDA guidance is on a case-by-case nature.

Basically, the FDA’s guidance is based on its working with large to very large clinical trials. It has thus far not seriously considered working with small groups for assessing premarketing clinical trial safety. At its barest, the FDA seeks to:

  • Advise sponsors or organizations undertaking the clinical trial about ways by which their data collection can be simplified so as to ensure that it is neither too huge nor too small, and should lead to giving insights about the drug’s safety. Essentially, the FDA guideline on premarketing clinical trial safety seeks to prevent sponsors from collecting data that is not relevant.
  • Get sponsors to consult the FDA’s review division for its premarketing clinical trial safety.

The FDA has different requirements for different kinds of studies that relate to clinical trials. For example:


Learn more  on this topic by visiting: http://bit.ly/Clinical-Trial-Practice-for-Drugs-and-Biologics

Supplier audit program

Supplier audit program

An internal audit program is needed for any business in which continuous work is needed, such as documentations. An audit ensures that the root cause of documentation is addressed. Documentation that is proper and process-oriented is a regulatory requirement, and hence an audit program is a must. A proper audit program that has tied loose ends up is a guarantee against any check from an external source, such as the FDA or an internal one, such as by the management or the firm’s partners.

The need for a supplier audit program

Why is a supplier audit program needed? In these days of globalization, most organizations, including medical devices and pharmaceuticals, outsource many of their operations. Products are manufactured in different locales, both locally and globally, before they are eventually consumed. A supplier audit program that is methodical, process oriented, transparent and scientific is the way to ensure that everything that goes into the manufacture and supply of these products is in line with set procedures and practices.

The criticality of the supply chain

The importance of and need for a supplier audit program needs to be understood in the context of an age where the geographical borders have blurred for global businesses. The supply chain, being the gel that holds the global business together, is stretched to different and diverse geographies. This is where the supplier audit program’s importance matters. A supplier audit program that is streamlined, visible and accountable is the best means to ensuring that the supply chain is robust and well-coordinated. This ensures smooth passage of the ingredients that to into the product, leading to hassle-free production, and eventually, profitable business.


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