FDA Updates for Health Professionals --June 20, 2012

U.S. Food and Drug Administration
Office of Special Health Issues
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

Dear Colleague,
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.

PRODUCT SAFETY: 
Nidek Medical Products, Inc. Issues an Urgent Medical Device Correction Affecting Oxygen Concentrators (Jun 18)
FDA has classified the voluntary recall action of Medical Mark5 Nuvo Lite Oxygen concentrators by Nidek Medical Products, Inc., as a Class I recall due to capacitor-related fires.
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion (Jun 15)
Expanded Class I Recall-Serial numbers range from 700000 through 794213. These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow.
Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena) (Jun 15)
FDA approved Makena (hydroxyprogesterone caproate) in February 2011 for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth.
Sandoz US Announces Precautionary Recall Of Oral Contraceptive Introvale®, Following Report Of Packaging Flaw (Jun 5)
Sandoz is conducting a voluntary recall of 10 lots of its generic oral contraceptive Introvale® in the US, following a recent report of a packaging flaw.
May 2012 Monthly Safety Labeling Changes May 2012 Monthly Safety Labeling Changes includes 41 products with revisions to Prescribing Information.
Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel (May 30)
FDA, the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health, and the Occupational Safety and Health Administration strongly encourage health care professionals to use blunt-tip suture needles as an alternative to standard suture needles when suturing fascia and muscle to decrease the risk of needlestick injury.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch.


PRODUCT APPROVALS: 
FDA approves new combination vaccine that protects children against two bacterial diseases (Jun 14)
FDA approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Yand Haemophilus influenzae type b.
FDA approves Perjeta for type of late-stage breast cancer (Jun 8)
FDA approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.
                                                                                 
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES: 
Reclassification from Schedule 3 to 2, of Combination Hydrocodone ProductsOctober 29-30, 2012 Drug Safety and Risk Management (DsaRM) Advisory Committee Meeting will discuss the reclassification from schedule 3 to 2, of combination hydrocodone products. The Committee will discuss the potential for abuse of drugs containing hydrocodone either combined with other analgesics or as an antitussive.  FDA opened docket number FDA-2012-N-0548. Submit comments by November 6, 2012.
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket NotificationsThe Agency intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. Submit either electronic or written comments by September 7, 2012.
Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; AvailabilityThis draft guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant setting using pathologic complete response as a surrogate endpoint that could support approval under the accelerated approval regulations.  Submit either electronic or written comments on the draft guidance by July 30, 2012.
UPCOMING MEETINGS: 
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 21)
Public Meeting - Clinical Study Design and Performance of Hospital Glucose Sensors (Jun 25)
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (Jun 27-28)
Risk Communication Advisory Committee (Jun 29)
Device Improvements for Pediatric X-ray Imaging (Jul 16)
Oncologic Drugs Advisory Committee Meeting (Jul 24-25)
Drug Safety and Risk Management Advisory Committee Meeting (Oct 29-30)

Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.


RESOURCES: 
Continuing Education
- Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and PharmacistsThe goal of this activity is to provide education to clinicians and pharmacists about risk evaluation and mitigation strategies.
- Safe Disposal of Medications and Sharps in the Home Setting – A CE program for nurses developed by FDA and ANA.  Stay tuned for more information.
 
Articles

Statins: The Story Behind the Label Changes
Videos 

- A Short Tutorial on REMS: The FDA PerspectiveFeaturing Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
- BioCentury This Week Interview: Patient-Centered Regulation. FDA’s Richard Klein on integrating patient advocates into a formal agency framework for risk-benefit decisions. National Health Council’s Marc Boutin on how benefit-risk is at the “intersection of data and values.”
Other Resources
MedWatch Safety Alerts for Human Medical ProductsYour FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. Follow us on Twitter to receive the MedWatch Safety Alerts: http://twitter.com/FDAMedWatch

For Health Professionals
Additional information for Health Professionals may be found on FDA’s Health Professional website.

MedSun Medical Product Safety NetworkThe Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety.
Up-to-date Electronic Labels on DailyMed and FDA's Online Label RepositoryWithin one business day, drug companies may now update their electronic content of labeling on DailyMed and the FDA Online Label Repository.
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
- Children and Asthma: The Goal Is Control
FDA VoiceFDA Voice is the official blog from FDA's senior leadership and staff. FDA Voice is a new forum and through upcoming blog posts you will find news, background, announcements and other information about the work done at the FDA on behalf of the American public.
- Blood Substitutes: Working to Fulfill a Dream


Best regards,

Office of Special Health Issues
Food and Drug Administration