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We post to our Web site latest FDA-483s, EIRs received from FDA pursuant to our FOIA requests, for Mark Adams, MD; Custom Ultrason...[ Price : $8.95]
CDERs Lawrence Lesko says the way in which Amgen and BMS/Imclone approached retrospective analysis of trial data for relabeling th...[ Price : $8.95]
FDA commissioner Margaret Hamburg says the agency wants to find ways to save regulated companies some money that they can invest i...[ Price : $8.95]
ReGen Biologics says FDAs decision to re-review its Menaflex 510(k) clearance has hurt the companys ability to raise operating cas...[ Price : $8.95]
FDA says that it identified potential signals of serious risks or new safety information in 13 drugs during the first quarter of t...[ Price : $8.95]
CDRH issues a guidance on changes in the medical device registration and listing program.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on implementing medical device establishment registration and device listing requ...