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Consumer Information on: Sientra Silicone Gel Breast Implants
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FDA/Xavier University Medical Device Conference, May 1-4, 2012
Podcast: The FDA Purchasing Controls Three Questions… Three Answers! In this brief, insightful podcast, Gina Brackett, Compliance Officer for the FDA, Office of Regulatory Affairs discusses the FDA’s approach to Purchasing Controls Listen to the Podcast Recent Training Event FDA Perspective Workshop: Purchasing Controls  TRAINERS: Gina Brackett, FDA; Laureen Geniusz, FDA; Ray Ursick, REU…
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (April 25-26, 2012)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration  [Docket No. FDA-2012-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting…
Brilliant Blue G: Recall of Unapproved Drug
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BMIS Zip Download File
Our apologies. The link or location you used does not exist or was moved. For the fastest assistance, please try one of the following options: TOPIC CONTACT INFORMATION Animal Veterinary Email: [email protected] Biologics, Blood, and Vaccines Email: [email protected] Cosmetics Email: [email protected] Tobacco Products Email: [email protected] Dockets Federal Register Documents Phone: 1-301-827-6860 Drugs Email: [email protected] Foods…
Guidance for Industry, Third Parties and Food and Drug Administration Staff
Document issued on: March 19, 2012 The draft of this document was issued on May 20, 2010. OMB control number: 0910-0700 Expiration Date: 02/28/2015 See additional PRA statement at the end of this guidance For questions regarding this document, contact Kimberly A. Trautman (CDRH) at 301-796-5515 or by email at [email protected], or the Center for…
Draft Guidance for Industry and Food and Drug Administration Staff – Class II Special Controls Guidance Document: Nucleic Acid
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.Document issued on: March 19, 2012 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management…
Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury
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Public Workshop
The purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we conclude negotiations for the next reauthorization of the medical device user fee program. Date, Time…