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Medical Devices

FDA OKs Siemens Somatom X.cite CT Scanner

FDA clears a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam Companion user interf...

FDA OKs Medtronic In.Pact Balloon

FDA approves a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing arteriovenous access i...

Human Drugs

Industry Attacks Dems Drug Price Plan

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

Human Drugs

WHO Draft Data Integrity Guidance

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

Transdermal, Topical Delivery System Guidance

FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on information to includ...

Federal Register

Comments Sought on Substances for Animal Compounding

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

Federal Register

Draft Guide on Animal Drug Compounding

Federal Register notice: FDA makes available a draft guidance for Industry #256 entitled Compounding Animal Drugs from Bulk Drug Substances.

Medical Devices

CDRH STeP Program Explanation

CDRHer Joshua Chetta outlines provisions in a draft guidance proposing the new Safer Technology Program for Medical Devices.

FDA General

Hahn Meets Praise, Resistance During FDA Confirmation

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

Federal Register

BLA for Thyroid Eye Disease Therapy to Panel

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