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FierceBiotech 03/20/2019 10:39
In the letter to J&J’s Mentor Worldwide and Acclarent units, the FDA said the companies had failed to meet enrollment milestones for recipients of its MemoryShape breast implant, which was approved in June 2013.
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GlobeNewswire 03/20/2019 03:00
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status for the ABSSSI indication.
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MedCity News 03/15/2019 13:48
Earlier last week, the FDA had recommended that clinical trials in oncology let in more patients with HIV and hepatitis B and C. The guidance, announced Friday in the Federal Register and posted to the FDA’s website, was a finalization of draft guidance issued previously ...
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Public Health Newswire 03/14/2019 10:29
Check out today’s public health news for Thursday, Mar. 14, 2019.
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FDLI SmartBrief 03/14/2019 09:56
New FDA draft guidance suggests the inclusion of patients with HIV, hepatitis B and hepatitis C in cancer clinical trials based on predetermined conditions.
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PR Newswire 03/12/2019 10:19
These guidances provide recommendations on how sponsors can safely and effectively broaden the criteria for the inclusion of certain patient populations in clinical trials, when appropriate, for pediatric patients, and patients with Human Immunodeficiency Virus, Hepatitis B and Hepatitis C Virus Infections, brain metastases, prior or concurrent malignancies or organ dysfunction.
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Healio News 03/08/2019 14:34
FDA accepts NDA for pretomanid in combination TB regimen.
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The FDA is expected to make a decision on approval by November 4, 2019.
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Zero Hedge 03/05/2019 15:14
Gottlieb spent much of his confirmation hearing talking about the opioid epidemic – comparing it to public health emergencies caused by the Ebola and Zika viruses – while acknowledging the FDA’s own unwitting contribution by granting approvals for the painkillers.
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