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Guidance on Draft Labeling to Support ANDAs

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Acceptability of Draft Labeling to Support ANDA Approval.

Guidance on CMC Changes for Drugs/Biologics

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Federal Register Notice: FDA reopens the comment period for a draft guidance on reportable chemistry, manufacturing, and controls ...

FDA Posts List of Approved PMAs

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Federal Register Notice: FDA publishes a list of PMAs that have been approved.

Use FTC Protocol for Off-label Promotion: Gulfo

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Rothman Institute director Joseph Gulfo suggests a way for FDA to back out of its objection to companies providing truthful and no...

Issues Found in GSK Aiken Inspection

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FDA releases an FDA-483 listing four observations from an inspection at GlaxoSmithKlines Aiken, SC, consumer healthcare facility.

Some Drug Price Hikes Related to FDA Safety

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Bloomberg Business says that an FDA effort to bring old unapproved drugs under modern regulation can lead to much higher prices fo...

FDA Safety Review Clears Zambons Monurol

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An FDA drug safety review of Zambons Monurol (fosfomycin) finds no new safety signals related to either parenteral or oral formula...

FDA Approves Alkermes Aristada for Schizophrenia

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FDA approves an Alkermes NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophreni...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites International Medical Development and MPH Nutrition.

Guide on Electronic Common Technical Document

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Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Versi...