On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rulehere.) The Webina...
According to the eBay settlement agreement, the government contends that from October 2015 to the present, eBay did not comply with any of “the CSA’s reporting and recordkeeping obligations” involving thousands of transactions. In addition to the tableting machines, the government alleged that e...
adverse event (AE) is serious and unexpected and there is a possibility the drug caused the event. Further, when deciding whether an AE should be reported, investigators should consider whether the event constituted an unanticipated problem that involves risk to human subjects or others. ...
specific retail store name and address) when recalled human or animal food is not easily identified as being the subject of a recall from its retail packaging or lack thereof (e.g., deli cheese,
美国FDA 指导原则 REMS评估计划和报告 英文原版.pdf,REMS Assessment: Planning and Reporting Guidance for Industry DRAFT GUIDANCE For questions regarding this draft document contact (CDER) Doris Auth 301-796-0487, or (CBER) Office of Communication, Outreach
After the initial notification, the FDA recommends that device makers provide updates every two weeks, along with expected timelines for recovery, even if the status has not changed. Notifications should include the reason for the discontinuance or interruption, along with appropriate identifying informa...
Medical Device Safety Evaluation Division oversees security administration of devices in markets, such as adverse event reporting, tracked devices, re-examination, re-evaluation, etc. MFDS (Korea FDA) works with NIFDS for a review of pre-market applications by 5 different divisions depending upon ...
or to receive this boilerplate response: “We appreciate your patience during this time. Unfortunately, we are not able to provide estimates of review timelines.” While the U.S. suffers from a shortage of tests, companies that raced to develop and validate tests are left in regulatory limbo...
a reduction in the occurrence of a known serious adverse event, a reduction in the occurrence of a known device failure mode, a reduction in the occurrence of a known use-related hazard or use error, or an improvement in the safety of another device or intervention. As to the first criter...
adverse event (AE) is serious and unexpected and there is a possibility the drug caused the event. Further, when deciding whether an AE should be reported, investigators should consider whether the event constituted an unanticipated problem that involves risk to human subjects or others. ...