Background As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In…
Webinar – Artificial Pancreas: A Dialogue between the FDA and the Diabetes Community
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April 2016 PMA Approvals
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Summary Information for: Epi proColon
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Meeting Materials posted for May 24, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Patient and Consumer Stakeholder Meeting Minutes, April 25, 2016
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Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication
[Posted 05/19/2016] AUDIENCE: Dermatology, Family Practice, Pharmacy, Patient ISSUE: FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit…
Well Care Compounding Pharmacy Sterile Compounded Products: Recall
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Canagliflozin (Invokana, Invokamet): Drug Safety Communication
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Evaluation of Automatic Class III Designation (De Novo) Classification Order (DEN140032 added)
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