The final guidelines to accelerate the development and production of vaccines to prevent bird flu and seasonal strains of influenza have been approved.
Proposed in March 2006, the recommendations were crafted to help manufacturers use newer technology that allows vaccines to be made more quickly once a strain of flu is identified, and to encourage more companies to get involved in making vaccines.
Under the final recommendations, the FDA outlined steps for companies wanting approval using new manufacturing methods such as cell cultures or advanced genetic technology.
The agency said that companies using either method would have to provide data from clinical trials. Companies interested in pursuing new technology, however, could test vaccines against various predictors of how well a product works and conduct trials later to confirm results.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs