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Dietary Supplement NDI Enforcement Discretion

[ Price : $8.95]

FDA publishes a draft guidance on possible enforcement discretion so dietary supplement companies can correct past failures to sub...

FDA Moving Toward Emerging Technology Regs: Kopcha

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CDER Office of Pharmaceutical Quality director Michael Kopcha says the agency is working on regulations to help companies become m...

CDRH Device Sterility Master File Pilot

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CDRH announces a new 510(k) Sterility Change Master File Pilot Program that is intended to give interested companies that terminal...

Drug Shortage Risk Management Guidance

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FDA publishes a draft guidance to help develop, maintain, and implement risk management plans to assist in preventing human drug s...

FDA Enterprise Modernization Plan Explained

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FDA principal deputy commissioner Janet Woodcock explains the components of the agencys new Enterprise Modernization Action Plan.

FDA Updates Philips Respironics Recall Info

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FDA updates its communications about Philips Respironics recalls of ventilators and BiPAP and CPAP machines.

ISPE Wants Longer Device Quality System Implementation

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Three medical device stakeholders express support for a proposed FDA change to the quality system regulation to incorporate an int...

Medical Journals Need Better Conflict Disclosures: Article

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Public Citizens Sidney Wolfe and Weill Cornell Medical College professor Martin F. Shapiro urge medical journals to step up their ...

Woodcock Assisting 7 Offices/Centers; Not Drugs/Biologics

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FDA commissioner Robert Califf taps FDA principal deputy commissioner Janet Woodcock to counsel and support seven offices and Cent...

Patel Joins Google Health

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Former FDA Digital Health Center of Excellence director Bakul Patel joins Google and Alphabet as a senior director for global heal...