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Federal Register notice: FDA makes available a medical device final guidance on principles for using patient-reported outcome inst...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Patient Engagement in the Design and Conduct of Medical Dev...[ Price : $8.95]
CDRH issues its annual report on the Accreditation Scheme for Conformity Assessment pilot program.[ Price : $8.95]
FDA publishes two guidances intended to help ANDA submissions.[ Price : $8.95]
Incyte says it is withdrawing an NDA for its parsaclisib to treat three lymphomas.[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America makes the case for amending Federal Rule of Evidence 702 to help dismiss spec...[ Price : $8.95]
CDER issues a MAPP on ANDA information requests and discipline review letters.[ Price : $8.95]
Philips Respironics recalls certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane...