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Info on Orphan Products Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a draft guidan...

Guidance on Study Data E-Submissions

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format Standardized Study Data.

Info on Biologic Cooperative Manufacturing Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Guidance on E-Format Submissions Under FDCA 745A(a)

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Federal Register Notice: FDA releases a guidance: Providing Regulatory Submissions in Electronic Format Submissions Under Section...

FDA Proposes Electronic Prescribing Info on Drugs/Biologics

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Federal Register Proposed rule: FDA proposed to amends is prescription drug and biological product labeling regulations to require...

FDA Mulls Changes to Drug-induced Liver Injury Guidance

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FDA seeks input on potential revisions to a 2009 guidance on Drug-Induced Liver Injury: Premarketing Clinical Evaluation, which is...

FDA Testing Drone Technology, But Not for Inspections

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FDA says it is testing drone technology as part of its Office of Informatics and Technology Innovation emerging technologies resea...

FDA Issues Form 483 After Inspection at Hovione Portugal Facility

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FDA issues Hovione a Form FDA-483 after conducting a pre-approval inspection at its plant in Loures, Portugal, covering two NDA fi...

GPhA Expresses Changes Being Effected Rule Concerns

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The Generic Pharmaceutical Association gives FDA officials an alternative proposal for making safety changes to generic drug label...

Woodcock Gets ISMP Lifetime Achievement Award

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FDA commissioner Margaret Hamburg congratulates CDER director Janet Woodcock on receiving the Institute of Safe Medication Practic...