FDA NEWS DIGEST -- MAY 20, 2002 SCHERING-PLOUGH AGREES TO PAY RECORD SETTLEMENT -- Schering-Plough Corp. has signed a consent agreement to pay $500 million to the U.S. Treasury, the highest monetary settlement in FDA history, after violating manufacturing regulations at the firm's New Jersey and Puerto Rico plants. The decree affects about 125 different prescription and over-the-counter drugs. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00809.html DRUG COMPANY ISSUES ALERT ON COUNTERFEIT AIDS DRUG -- Serono Inc. has become aware of a counterfeit lot of the company's AIDS wasting treatment Serostim and is alerting pharmacists to examine packaging before dispensing. Preliminary information indicates the counterfeit drug may have been distributed through the Internet. http://www.fda.gov/oc/po/firmrecalls/serono05_02.html FDA SITE ON PREGNANCY REGISTRY DEBUTS -- FDA's Office of Women's Health has created a site that provides information about several pregnancy registries and how pregnant women can participate. The registries are surveillance studies that enroll pregnant women who have taken or are still taking certain medications during pregnancy. http://www.fda.gov/womens/registries/default.htm _________________________________________________________________ Thanks for subscribing to the FDA News Digest. The next posting will be sent May 28. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV. In the body of the message, write "SIGNOFF FDA-NEWSDIGEST-L"
