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Attorney Jeffrey Shapiro says companies should be careful when calculating for FDA the risk of a medical device malfunction.[ Price : $8.95]
A CDRH official says a new draft cybersecurity guidance has teeth that make it more likely that companies that follow its recommen...[ Price : $8.95]
Federal Register notice: FDA announces that it is withdrawing approval of a Secura Bio indication for Copiktra (duvelisib) for tre...[ Price : $8.95]
FDA places a clinical hold on an Ocugen Phase 2/3 immuno-bridging and broadening study for its Covid-19 vaccine Covaxin (BBV152) a...[ Price : $8.95]
FDAs Bioresearch Monitoring Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator and I...[ Price : $8.95]
Four medical device stakeholders call for changes to an FDA draft guidance on notifying the agency in advance of a public health e...[ Price : $8.95]
Two stakeholders suggest changes to an FDA draft guidance on developing non-opioid analgesics for acute pain.[ Price : $8.95]
Myovant Sciences and Pfizer say FDA has told them that it found deficiencies in a supplemental NDA on Myfembree (relugolix 40 mg, ...