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Device Guide on Patient-Reported Outcome Instruments

[ Price : $8.95]

Federal Register notice: FDA makes available a medical device final guidance on principles for using patient-reported outcome inst...

Guide on Patient Engagement in Device Trial Designs

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Patient Engagement in the Design and Conduct of Medical Dev...

ASCA 2021 Annual Report

[ Price : $8.95]

CDRH issues its annual report on the Accreditation Scheme for Conformity Assessment pilot program.

FDA Good ANDA Submission Practices Guidance

[ Price : $8.95]

FDA publishes two guidances intended to help ANDA submissions.

Incyte Pulling Parsaclisib NDA

[ Price : $8.95]

Incyte says it is withdrawing an NDA for its parsaclisib to treat three lymphomas.

PhRMA Backs Changes to Evidence Rule 702

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America makes the case for amending Federal Rule of Evidence 702 to help dismiss spec...

ANDA Information Request MAPP

[ Price : $8.95]

CDER issues a MAPP on ANDA information requests and discipline review letters.

Philips Respironics Recalls Trilogy Evo Ventilators

[ Price : $8.95]

Philips Respironics recalls certain Trilogy Evo ventilators due to potential health risks caused by a polyester-based polyurethane...

Immunocore BLA for Melanoma Approved

[ Price : $8.95]

FDA approves an Immunocore BLA for Kimmtrak (tebentafusp-tebn) for treating certain adult patients with unresectable or metastatic...

Gilead Partial Clinical Hold on Magrolimab Trials

[ Price : $8.95]

FDA places a partial clinical hold on Gilead Sciences studies evaluating the combination of magrolimab plus azacitidine (Celgenes ...