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CDRH policy analyst Allen Hill explains the voluntary 510(k) third-party review program in a Webinar presentation.[ Price : $8.95]
CBER releases the transcript from a 3/3 public workshop on individualized therapeutics regulated by the Center.[ Price : $8.95]
FDA issues a refusal to file letter to Bristol Myers Squibb and Bluebird Bio for a BLA for idecabtagene vicleucel, indicated for t...[ Price : $8.95]
MasterPharm recalls one lot of finasteride plus 1.25mg capsules because they were found to contain higher levels of minoxidil, an ...[ Price : $8.95]
A National Academies report finds no evidence to support the safety or effectiveness of compounded topical pain creams.[ Price : $8.95]
FDA releases for public viewing a memorandum of understanding between the agency and states on regulation of drug compounding.[ Price : $8.95]
Vanda Pharmaceuticals says it has reached agreement with FDA to resubmit an NDA and supplemental NDA for Hetlioz (tasimelteon) for...[ Price : $8.95]
FDA clears a Royal Philips 510(k) for ultrasound options for managing Covid-19-related lung and cardiac complications.