GMP News No. 445
3 August 2004
FDA Strategy -
On 7 July, the Acting Commissioner of the FDA, Dr Lester M. Crawford, presented the cornerstones of the FDA's future targets to a selected audience.
In the following we have compiled some extracts from this presentation.
One of FDA's main targets is the reduction and prevention of health risks. Owing to the complexity of FDA's supervisory activities, according to Crawford, this task can only be fulfilled with the help of an effective risk management. He even sees this approach to be a sine qua non for the FDA.
Another focus of the FDA is to protect and improve the health of US citizens. For this reason, the FDA intends to facilitate efficiency in the development and manufacture of medicinal products. In this same light, Crawford also sees the modernisation of the FDA. Especially FDA's 'drug review,' the 'compliance' and the inspections should be based on 'state-of-the-art pharmaceutical science.' This is meant to lead to a higher quality and, at the same time, reduced costs. According to Crawford, one means to get on this way is an exchange of ideas also outside the Agency. Above all the International Conference on Harmonisation (ICH) was mentioned expressly by him.
Another possibility is the modernisation of the FDA inspection programme. Comparable to the Team Biologics, which made considerable contributions to improving the quality and safety of biological products on the one hand and the coordination between the 'centers' and the 'field' on the other hand, a Pharmaceutical Inspectorate is planned to be founded. This Pharmaceutical Inspectorate will consist of specialists from CDER and from the Office of Regulatory Affairs (ORA). These experts will undergo a specific training enabling them to assess and supervise in particular highly risky and complex pharmaceutical activities - also within the framework of pre-approval inspections.
Further cornerstones of the FDA programme are:
By 'combination products,' FDA understands therapeutics that combine medicinal products, biologics and/or medical devices. In order to render the regulatory requirements on these products more transparent, the Office of Combination Products (OCP) was founded one and a half years ago.
You can read the unabridged text of Dr Crawford's presentation if you click here.
PS. Another item that has been revised is FDA's Guidance Document Agenda. It
contains a list of documents that are meant to be published for the first
time or updated. It is e.g. interesting that the FDA is planning to
publish a guideline on reprocessing and reworking of biologic APIs and
medicinal products. This
link will lead you to the document.
Compliance with FDA requirements is one of
the key topics covered by the European Compliance Academy. Among others
the following courses have a special focus on FDA: