FDA News Digest August 11, 2003 ______________________________________________________________ FDA Rule Will Help Speed Access to Generic Drugs, Save Billions FDA is about to implement a rule that will help speed the approval of generic drugs and should result in billions of dollars in health care savings for consumers. The rule will prevent innovator drug companies from submitting certain new patent claims in order to extend marketing protection, which delays approval of generic, less-expensive equivalents. The rule becomes effective Aug. 18. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00932.html ______________________________________________________________ FDA Sets New Goal to Shorten Review Times for Medical Devices Using resources provided under the Medical Device User Fee and Modernization Act, FDA has set a new goal of reducing the time the agency takes to review applications for marketing medical devices. As part of the program, the agency will work with device sponsors to help them improve the quality of applications they submit. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00929.html ______________________________________________________________ Photofrin Approved to Treat Precancerous Lesions in Barrett's Esophagus FDA has approved the injected drug Photofrin to treat precancerous lesions in Barrett's esophagus patients who do not undergo surgery to remove the esophagus. Barrett's esophagus is a condition in which some of the lining of the esophagus is replaced by a type of tissue similar to that in the intestine. Photofrin is a photosensitizing agent that treats some types of cancer when combined with exposure to a certain type of light. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01246.html ______________________________________________________________ Medical Device Reprocessor Agrees to Correct Manufacturing Problems Through a court ordered injunction, Adven Medical Inc. has agreed to stop reprocessing and distributing medical devices such as catheters and sutures until the company corrects manufacturing problems FDA found during inspections. Medical facilities often use reprocessed devices because they are less expensive than new ones. FDA has worked aggressively to ensure that medical device reprocessors take appropriate steps to make sure reprocessed devices are safe and work properly. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00931.html ______________________________________________________________ Las Vegas Man Pleads Guilty to Distributing Prescription Drugs on Internet Christian Finze, a Las Vegas businessman, has pleaded guilty to distributing prescription drugs illegally over the Internet. Court documents showed that Finze was involved in shipments that included the drug Flunitrazepam, commonly known as Rohypnol, or the "date-rape drug." Flunitrazepam is not approved for manufacturing or distribution in the United States. FDA's Office of Criminal Investigations investigated the case, along with the Bureau of Immigrations and Customs Enforcement. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00930.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be August 18. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
