FDA Conducts Workshop for Small Pharmaceutical Businesses

GMP News No. 747

GMP News
19 June 2006

FDA Conducts Workshop for Small Pharmaceutical Businesses

A workshop organised by the Food & Drug Administration (FDA) and the U.S. Small Business Administration (SBA) specifically addressed small and midsized drug manufacturers. The workshop took place in April and aimed at providing first hand information for pharmaceutical companies relative to GMP and pre-market requirements, compliance as well as to current OTC and generic drug issues.

FDA presentations focused on topics like regulatory aspects and challenges in realising them, the agency's available support for a successful and efficient product development, the processes businesses have to follow in product approvals and the existing resources.

The FDA "Small Business Representatives Program" also specifically supports small and midsized companies – e.g. through facilitating them to easier access guidances, regulations and the Federal Register or by guiding them through problems, providing technical support or acting as liaison.

In addition the businesses can get support by the SBA – offering financial programmes, special trainings and consulting services.

Following you will find information on the "Small Pharmaceutical Business Educational Forum Public Workshop as well PDFs of the presentations:


FDA requirements are also in the centre of the following ECA course:

GMP Compliance Auditor Course "How to Pass EU and FDA Inspections" from 4-6 October in Barcelona, Spain.

Prepared by:
Wolfgang Heimes
On behalf of the European Compliance Academy (ECA)


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