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:
http://www.fda.gov/cder/meeting/de-forum-2006.htm#presentations
|
