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Stakeholder Input on Innovative Trial Workshop

[ Price : $8.95]

Five stakeholders suggest possible topics for an upcoming FDA workshop on innovative drug clinical trials.

Groups Urge Hearing on CBD Regulation

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Twenty-eight non-profit groups representing the CBD (cannabidiol) and hemp industries call on Congress to hold a hearing to unders...

ANDA Final Approval Guidance

[ Price : $8.95]

FDA publishes an updated guidance incorporating GDUFA 3 performance goals on amendments and requests for final approval to tentati...

Theratechnologies Complete Response on Tesamorelin

[ Price : $8.95]

FDA sends Theratechnologies a complete response letter on its supplemental BLA for an F8 formulation of Egrifta SV (tesamorelin), ...

Info Collection on Radiopharmaceuticals

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Regulations for In Vivo Radiopharmaceutical...

4 Priority Review Vouchers Redeemed: FDA

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Federal Register notices: FDA posts four announcements about a priority review voucher being redeemed as part of a product approva...

CDRH Tech Innovation Group Now a Super Office

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CDRH says its Office of Strategic Partnerships and Technology Innovation has been elevated to a super office.

Positive Gene Therapy Results for Some Hearing Loss

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A Lilly subsidiary says its investigational gene therapy for some genetic hearing loss showed positive results in a Phase 1/2 tria...

Haleon Recalls 8 Robitussin Lots

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Haleon recalls eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult due to microbial contam...

Breakthrough Status for Colorectal Cancer Test

[ Price : $8.95]

FDA grants Amadix a breakthrough device designation for PreveCol, a blood test for early detection of colorectal cancer.