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Vericels Maci Approved for Knee Cartilage Repair

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FDA approves a Vericel PMA for Maci (autologous cultured chondrocytes on porcine collagen membrane) for repairing symptomatic, ful...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Pocono Coated Products and United Contact Lens.

President Obama Signs Cures Act Into Law

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President Obama signs into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 1...

FDA Speeds Up Drug Safety Labeling Changes Notifications

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FDA says it has speeded up the release of drug safety information on its Web site that houses labeling changes made post approval.

Centurion Class 1 Recall of Catheters

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Centurion begins a Class 1 recall of its Multi-Med Single Lumen Catheters due to excess material at the tip that may split or sepa...

Sodium Chloride 23.4% Eligible For Generic Approvals

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Federal Register Notice: FDA determines that sodium chloride 23.4% in a plastic container (sodium chloride), injectable, 234 milli...

Guidance Relaxes Requirements for Hearing Aids

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Federal Register Notice: FDA makes available a guidance entitled Immediately in Effect Guidance Document: Conditions for Sale for ...

Praise, Suggestions for 510(k) Guidance

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Washington Legal Foundation makes several suggestions for changes to an FDA draft guidance on when to submit a new 510(k) for a ch...

Ophthotech Eye Drug Fails Phase 3 Trials

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Ophthotech says two Phase 3 studies evaluating its wet age-related macular degeneration drug Fovista (pegpleranib) failed to meet ...

MDMAs Concerns on FDA UDI Information Collection

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MDMA says it disagrees with an FDA industry cost estimate in its draft guidance on information collecting for the unique device id...