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GDUFA Reauthorization Aids Public Health: FDA Execs

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CDER executives say that GDUFA reauthorization helps public health by providing funds for the Centers work to bring generic drugs ...

FDA Clears DePuy 510(k) for Maxframe Fixation Device

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FDA clears a DePuy Synthes 510(k) for its recently launched Maxframe Multi-Axial Correction System, an external circular fixation ...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Diasol and Kelyniam Global.

ICH Approves 2 Guidances

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The International Council for Harmonization announces approval of two guidances and a question-and-answer document.

Teva Files BLA for Migraine Prevention Therapy

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Teva Pharmaceutical Industries files a BLA for fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for preve...

FTC Expanding Enforcement Theories: Legal Analysis

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Three attorneys look at the FTCs expanded efforts to regulate the line between permitted and potentially anticompetitive conduct b...

Court Dismisses Most Allegations in Generic Cordarone Suit

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A Kentucky federal court dismisses a suit against Zydus raising seven allegations about the companys generic form of Cordarone.

Class 2 for Enzyme Packed Cartridges

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Federal Register notice: FDA classifies enzyme packed cartridges into Class 2 (special controls).

FDA Corrects Docket Number on 27 Withdrawn ANDAs

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Federal Register notice: FDA corrects a 9/21 Federal Register notice that announced the withdrawal of approval of 27 abbreviated n...

Draft Guide on Complete Response Meetings

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Federal Register notice: FDA makes available a draft guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA...