On March 27, the FDA published a notice identifying 25 drugs and biologic products currently on the market that will be required to submit a REMS to the agency under the FDAAA.  A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product.  It can include a medication guide, patient package insert, communication plan, and elements to assure safe use (such as provider training and patient monitoring), and it must include a timetable for assessment of the REMS.  The FDA may require manufacturers to submit a REMS when a drug first comes on the market or later if FDA becomes aware of new safety data.  Proposed REMS for the products identified in the notice must be submitted by September 21, 2008.  In a press release, the FDA states that it also is implementing its new authority for drugs that will be approved after March 25, 2008, as well as for currently-marketed drugs for which new risks are identified after March 25.  The FDA also requests public input regarding whether REMS are appropriate for other drugs.