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FDA Changes Some Requirements for Generic Miacalcin

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FDA grants some restrictions on ANDA and 505(b)(2) applications for salmon calcitonin nasal spray products sought by Miacalcin Nas...

Barton Seeks GAO Study on FDAs Heparin Actions

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Texas Republican Joe Barton calls for a thorough GAO study on FDAs handling of the tainted heparin issue, calling into question th...

Harmonized Device Documents Available for Comment

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Federal Register Notice: FDA releases and seeks comments on a harmonized proposal on regulatory requirements for medical devices p...

Essential Use Epinephrine Removed for Inhalers

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Federal Register Final rule: FDA removes the essential use designation for epinephrine in oral pressurized metered-dose inhalers.

Medtronic Complying with Infuse Off-label Subpoena

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Medtronic says it is complying with a Department of Justice subpoena for information on off-label promotion of its Infuse spinal b...

Advisors Back Telavancin for Skin Infections

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FDAs Anti-infective Drugs Advisory Committee says Theravances telavancin is safe and effective for complicated skin and skin struc...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Bio-Safe America, Deltex, Innovative Neurotronics, George LeMaitre, Omega Tech L...

Process Validation Draft Guidance Out

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Federal Register Notice: FDA releases a draft guidance on process validation.

Info on State Enforcement Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on state enforcement notifications to OMB.

Panel to Vote on Genzymes Knee Treatment

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Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will vote on a Genzyme PMA for Synvisc-One.