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Guidance on Changes to Blood Product Application

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Changes to an Approved Application: Biological Products: Human Blood and Blood C...

FDA Corrects Notice on REMS

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Federal Register Notice: FDA corrects the name of an organization a 9/23 notice on report on the standardization of risk evaluatio...

Workshop on Drug Development and Rare Subsets of Patients

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Federal Register Notice: FDA plans a public workshop 12/12 on developing therapies in the omics era and using rare subsets of pati...

Panel to Discuss Astellas NDAs for Aspergillosis/Mucormycosis

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 1/22/15 to discuss Astellas Pharma NDAs for treati...

Baxter Recalls 1 Lot of Potassium Chloride Injection

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Baxter International recalls one lot of highly concentrated potassium chloride injection, 10 mEq per 100 mL due to a complaint of ...

Device Makers Need More Cybersecurity Input from FDA: Consultant

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Vree Health compliance officer Paige Joyner says medical device makers need more specific guidelines on what they need to do to he...

FDA Grants ChemoCentryx Orphan Status for CCX168

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FDA grants ChemoCentryx an orphan drug designation for CCX168 for treating atypical Hemolytic Uremic Syndrome.

Hamburg Signs Agreement with China on Inspection Collaboration

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FDA commissioner Margaret Hamburg concludes her trip to China this week by signing an arrangement with Chinese officials to collab...

House Appropriations Retains Aderholt to Handle FDA Budget

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House Appropriations Committee leaders choose to retain Rep. Robert Aderholt (R-AL) as chair of the Agriculture and Rural Developm...

Baxter Recalls Intravia Empty Containers

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Baxter Healthcare begins a Class 1 recall of its Intravia Empty Container with PVC Ports (sterile, fluid path) due to visible part...