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Academy Urges Broader Info Sharing Among Regulators

[ Price : $8.95]

A new report by the National Academy of Sciences recommends that regulators like FDA need to make increased use of reliance and co...

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

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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

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

eCTD Promotion Submission Errors

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CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD ...

WHO Draft Data Integrity Guidance

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

Transdermal, Topical Delivery System Guidance

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FDA issues a draft guidance with recommendations for applicants and manufacturers of transdermal and topical delivery systems on i...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

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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Federal Register notice: FDA makes available a draft guidance for Industry #256 entitled Compounding Animal Drugs from Bulk Drug S...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CDRHer Joshua Chetta outlines provisions in a draft guidance proposing the new Safer Technology Program for Medical Devices.