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National Center for Toxicological Research Panel Meeting 12/3-4

[ Price : $8.95]

Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory ...

Class 1 for Continuous Glucose Monitor Data Systems

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Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls).

AstraZeneca Positive Results for Imfinzi in Lung Cancer

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AstraZeneca announces positive progression-free survival results from the Phase 3 POSEIDON trial in previously-untreated Stage IV ...

Breakthrough Status for Medtronic Heart Pump

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Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with a...

Electronic Format for IND Safety Reports

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FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adve...

Drug Shortage Causes, Solutions

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An FDA-led drug shortage task force releases a report highlighting key reasons for drug shortages and potential enduring solutions...

Guide on Type V DMFs for CDER-Led Combo Products

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Federal Register notice: FDA makes available a draft guidance for industry entitled Type V DMFs for CDER-Led Combination Products ...

Class 2 for Air-Conduction Hearing Aids

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Federal Register notice: FDA classifies self-fitting air-conduction hearing aids into Class 2 (special controls).

FDA Withdrawing Watson Labs Oxycodone Hydrochloride

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Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen...

FDA Withdrawing InvaGen Trandolapril ANDA

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Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.