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:
Reumofan Plus: Recall - Undeclared Drug Ingredient (Jun 1)FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful. A Spanish-language version of this announcement can be found here.
MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall (Jun 1)There is a potential for a reverse pump segment in the administration set. This malfunction could reverse the flow of fluid or medicines backwards from what was intended.
V Maxx RX: Recall - Undeclared Drug Ingredient (May 29)
The Menz Club, LLC issued a nationwide recall of V Maxx Rx due to undeclared sulfoaildenafil, which is an analog of sildenafil. Sildenafil is an FDA approved prescription drug used to treat Erectile Dysfunction (ED), making V Maxx Rx an unapproved new drug.
FDA warns consumers about counterfeit version of Teva’s Adderall (May 29)FDA is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket NotificationsThe Agency intends for this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Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated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 (preoperative) setting using pathologic complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations. To ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 30, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot StudyThis notice solicits comments on the survey entitled “Medical Device Decision Analysis: A Risk-Tolerance Pilot Study.” Submit either electronic or written comments by June 18, 2012.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and CertificationThis notice solicits comments on Form FDA 3602 and Form FDA 3602A, which will allow domestic and foreign applicants to certify that they qualify as a “small business” and pay certain medical device user fees at reduced rates. Submit either electronic or written comments by June 18, 2012.
ANNOUNCEMENTS:
Recent Spanish versions of Drug Safety Communications: (Given various time and review constraints, availability of Spanish language versions of Drug Safety Communications will generally follow the English version by about 1-2 weeks.)
- Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)
- Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para observación cardiovascular y uso del medicamento Gilenya (fingolimod) para la esclerosis múltiple
UPCOMING MEETINGS:
15th Annual FDA-OCRA Educational Conference (Jun 6-7)
Regulation of Pharmaceuticals: A Global Perspective (Jun 6-8)
Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge, Public Workshop (Jun 7)
Blood Products Advisory Committee Meeting (Jun 12)
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 13)
Oncologic Drugs Advisory Committee Meeting (Jun 20)
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)
Please visit FDA’s Advisory Committee page (http://www.fda.gov/
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.
Articles
Statins: The Story Behind the Label Changes
Videos
- A Short Tutorial on REMS: The FDA Perspective
Featuring 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.”
FDA Drug Safety Podcasts
- Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)
MedWatch Safety Information Resources for Busy Physicians
http://www.youtube.com/watch?
A video discussing Medwatch Safety Alerts
Other Resources
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.
Availability of up-to-date electronic labels on DailyMed and FDA's new FDA Online Label Repository
Within one business day, drug companies may now update their electronic content of labeling on DailyMed and the FDA Online Label Repository.
FDA MedWatch Twitter
http://twitter.com/#!/
Your FDA gateway for receiving clinically important safety information on human medical products is now on Twitter. Follow us on Twitter to receive the MedWatch Safety Alerts: http://twitter.com/FDAMedWatch
For Health Professionals
http://www.fda.gov/
Additional information for Health Professionals may be found on FDA’s Health Professional website.
MedWatch Safety Alerts for Human Medical Products
http://www.fda.gov/Safety/
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
Database Is One-Stop Resource on Kids' Medications
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.
FDA Drug Info Rounds
http://www.fda.gov/Drugs/
A series of training videos for practicing clinical and community pharmacists.
Device Use Safety Tips
http://www.fda.gov/
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks.
FDA Patient Safety News
http://www.accessdata.fda.gov/
FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.
FDA Basics
http://www.fda.gov/AboutFDA/
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.
Best regards,
Office of Special Health Issues
Food and Drug Administration
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