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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Washington Legal Foundation makes several suggestions for changes to an FDA draft guidance on when to submit a new 510(k) for a ch...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MDMA says it disagrees with an FDA industry cost estimate in its draft guidance on information collecting for the unique device id...

FDA Issues Form-483 to Alkem Labs in India

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FDA issues Alkem Laboratories a three-item Form-483 after an inspection recently concluded at the firms Ankleshwar, India active p...

Clarifications Sought in Advisors Conflict Guidance

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Advocacy groups raise issues with a draft FDA guidance on evaluating appearance issues with advisory committee members.

Cures Act Medical Device Implications Explained

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Three Akin Gump attorneys review 21st Century Cures provisions affecting medical devices.

FDA Updates Actos Bladder Cancer Risk

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FDA says it has approved updated labeling for drugs containing pioglitazone covering additional studies showing a potentially incr...

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.