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A new report by the National Academy of Sciences recommends that regulators like FDA need to make increased use of reliance and co...[ Price : $8.95]
FDA clears a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam C...[ Price : $8.95]
FDA approves a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing ar...[ Price : $8.95]
Three major pharmaceutical sector stakeholders say an analysis they commissioned shows that the number of new medicines would drop...[ Price : $8.95]
CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD ...[ Price : $8.95]
The World Health Organization releases for comment a draft guideline on a risk-based approach to data integrity.[ Price : $8.95]
FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on i...[ Price : $8.95]
Federal Register notice: FDA establishes a public docket for interested parties to nominate bulk drug substances or re-nominate bu...