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Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall
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Draft Guidance for Industry – Providing Regulatory Submissions in Electronic Format
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CDRH Transparency: 515 Program Initiative Status Update
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Public Workshop
The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Design and Methodology for Postmarket Surveillance Studies under Section 522 of the Federal Food, Drug and Cosmetic Act.†This workshop is open to all interested parties, including professionals in the scientific community interested in advancing the infrastructure and methodology for postmarket surveillance studies….
FDA Safety Communication: Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes
Date Issued: Feb. 16, 2012 Audience: Consumers who use or may purchase the Crest and/or Arm Hammer Spinbrush Parents and caregivers who use or may purchase the Crest and/or Arm Hammer Kid’s Spinbrush Health care professionals including dentists, dental hygienists and dental assistants who recommend the Crest and/or Arm Hammer Spinbrush Medical Specialty: Pediatrics, Dentistry…
Evaluation of Automatic Class III Designation (De Novo) Decision : K102333 Approval Letter added
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Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication
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FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning
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Avastin (bevacizumab): Counterfeit Product
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