But they do "not in any way" require the same level of evidence as is needed for full marketing approval.

The first drug in this class was aliskiren, which received a marketing approval in 2007.

The company hopes to receive marketing approval from the Food and Drug Administration within two years.

Under this proposal, drug companies applying for marketing approval would underwrite some of the agency's administrative costs.

The researchers would like to conduct a larger study and include children as young as 2 or 3 and then seek marketing approval.

But the new proposals would, for the first time, lower the hurdles required for marketing approval.

The agency would not comment on the prospects for full marketing approval of aerosol pentamidine.

Both companies received marketing approval for their drugs in June.

How many applications for such marketing approval have been submitted to the European Commission?

How will the Commission ensure that a decision can be reached in good time on all pending applications for marketing approval?