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FDA OKs Siemens Somatom X.cite CT Scanner

[ 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...

FDA OKs Medtronic In.Pact Balloon

[ 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...

Industry Attacks Dems Drug Price Plan

[ Price : $8.95]

Three major pharmaceutical sector stakeholders say an analysis they commissioned shows that the number of new medicines would drop...

WHO Draft Data Integrity Guidance

[ Price : $8.95]

The World Health Organization releases for comment a draft guideline on a risk-based approach to data integrity.

Transdermal, Topical Delivery System Guidance

[ Price : $8.95]

FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on i...

Comments Sought on Substances for Animal Compounding

[ Price : $8.95]

Federal Register notice: FDA establishes a public docket for interested parties to nominate bulk drug substances or re-nominate bu...

Draft Guide on Animal Drug Compounding

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Federal Register notice: FDA makes available a draft guidance for Industry #256 entitled Compounding Animal Drugs from Bulk Drug S...

CDRH STeP Program Explanation

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CDRHer Joshua Chetta outlines provisions in a draft guidance proposing the new Safer Technology Program for Medical Devices.

Hahn Meets Praise, Resistance During FDA Confirmation

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FDA commissioner nominee Stephen Hahn sails through his Senate confirmation hearing 11/20 with praise and some resistance from law...

BLA for Thyroid Eye Disease Therapy to Panel

[ Price : $8.95]

Federal Register notice: FDA announces a 12/13 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Horizon ...