U.S. Food and Drug Administration
Office of Special Health Issues
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Silver Spring, Maryland 20993
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall - Potential For Balloon To Not Deflate Or To Deflate To Slowly (Mar 13) Acclarent received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned.
Gerber Good Start Gentle Powdered Infant Formula: Recall - Off-Odor (Mar 9) Gerber notified the public that it recalled one lot of Gerber Good Start Gentle Powdered Infant Formula, 23.2 ounce plastic package, because the affected product might have an off-odor noticeable to some consumers.
Guidance Outlines How FDA Communicates, Prioritizes Drug Safety Issues (Mar 8)
Recent guidance from the Agency outlines how CDER develops and disseminates drug safety information, and classifies drug safety issues.
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component (Mar 2) FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect.
Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury (Mar 1) FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs.
For more product safety information, please visit our MedWatch website.
FDA approves new silicone gel-filled breast implant (Mar 9) FDA approved a silicone gel-filled breast implant to increase breast size in women at least 22 years old and to rebuild breast tissue in women of any age.
FDA approves first cell-based product to treat oral mucogingival conditions in adults (Mar 9) FDA approved GINTUIT, the first cell-based product made from allogeneic human cells and bovine collagen. GINTUIT is indicated for topical application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
FDA approves Surfaxin to prevent breathing disorder in premature infants (Mar 6)
FDA approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome, a breathing disorder that affects premature infants.
FDA approves two new pancreatic enzyme products to aid food digestion (Mar 1)
Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by FDA.
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Draft Guidance for Industry: Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements provision of the FD&C Act. Submit either electronic or written comments on the draft guidance by May 14, 2012.
Draft Guidance: Classifying Significant Postmarketing Drug Safety Issues This draft guidance describes FDA's current approach to classifying a significant postmarket drug safety issue as a "priority" tracked safety issue (TSI) or a "standard" TSI, with the capability of elevating some priority TSIs to an "emergency" status. Submit either electronic or written comments on the draft guidance by May 8, 2012.
Draft Guidance: Drug Safety Information -- FDA's Communication to the Public This draft guidance describes FDA's current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors that influence when the information is communicated. Submit either electronic or written comments on the draft guidance by May 8, 2012.
Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products This draft guidance provides the pharmaceutical industry with CDER's current thinking on the potential human health risks associated with exposure to DBP and DEHP. Submit either electronic or written comments on the draft guidance by May 31, 2012.
Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs Submit either electronic or written requests for oral presentations and comments by March 9, 2012. Either electronic or written comments will be accepted after the hearing until May 7, 2012.
Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage: Draft Guidance (Feb 21) Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: Draft Guidance (Feb 9)
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance
Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Draft Guidance: Draft Guidance (Feb 9)
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
FDA Statement about Product Quality of Parenteral Vancomycin Products (Mar 9)
FDA performed testing on five parenteral generic vancomycin products and one brand name vancomycin product. The testing revealed no evidence of quality issues for the vancomycin products tested.
FDA issues warning letter to makers of AeroShot "caffeine inhaler" (Mar 6) FDA issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the "caffeine inhaler." FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol.
Meeting of the Oncologic Drugs Advisory Committee (Mar 20)
Meeting of the Oncologic Drugs Advisory Committee (Mar 21)
Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs (Mar 22 – 23)
Meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee (Mar 23)
Meeting of the Cardiovascular and Renal Drugs Advisory Committee (Mar 27)
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Mar 28-29)
Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee (Apr 2)
Meeting of the Reproductive Health Drugs Advisory Committee (Apr 5)
Meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee (Apr 11 – 12)
Role of Naloxone in Opioid Overdose Fatality Prevention; Request for Comments; Public Workshop (Apr 12)
FDA/Drug Information Association (DIA) Cardiovascular Safety and State-of-the-art Development Issues (Apr 17 – 18)
FDA/ASCO Public Workshop on Minimal Residual Disease (Apr 18)
Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing (Apr 23-24)
Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments (May 11)
Assessment of Analgesic Treatment of Chronic Pain: A Scientific Workshop (May 30-31)
The Clinical Investigator's CME Program: Transforming a Clinician Into an Investigator: What Does It Take? Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA. This CME/CE activity will help clarify the responsibilities of clinical investigators and address some of the challenges that investigators face today.
Statins: The Story Behind the Label Changes
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.
Please visit Articles of Interest to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals.
What To Do About Misleading Drug Ads A video discussing FDA's Bad Ad Program Featuring Michael Sauers, Team Leader for FDAs Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research.
FDA Drug Safety Podcasts Podcasts
Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury (Mar 2)
Important safety label changes to cholesterol-lowering statin drugs (Mar 2)
Consumer Updates: Mercury Poisoning Linked to Skin Products (Mar 6)
FDA Voice--the official blog from FDA's senior leadership and staff : Report Adverse Events and Sign Up to Get Medical Product Information with MedWatch (Mar 13)
New and Generic Drug Approvals
2011 Novel New Drugs (Mar 5)
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