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:
Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 Mg/500 Mg (Watson Laboratories): Recall - Potential For Oversized And Superpotent Tablets (Sep 24)
The
effected lot numbers are 519406A and 521759A, both with the expiry date
April 2014, and were distributed between 6/27/2012 and 7/18/2012 to
wholesale distributors and retail pharmacies nationwide.
Testing
revealed the presence of undeclared tadalafil and sildenafil, the
active ingredients in FDA-approved drugs for Erectile Dysfunction (ED).
Results of recent studies suggest a potential risk of heart failure that needs further review of available data.
As
part of an ongoing and proactive effort to monitor food safety and
address contaminants in food, FDA released preliminary data on arsenic
levels in certain rice and rice products.
Intestinominica
contains the prescription drug ingredient, chloramphenicol, which was
withdrawn from the United States market in July 2012 due to the risk of
serious and life threatening injuries.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatchPRODUCT APPROVALS:
FDA Approves First Breast Ultrasound Imaging System For Dense Breast Tissue (Sep 18)
For
use in combination with a standard mammography in women with dense
breast tissue who have a negative mammogram and no symptoms of breast
cancer.
http://www.accessdata.fda.gov/
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
FDA
is proposing to establish a unique device identification system to
implement the requirement added to the Federal Food, Drug, and Cosmetic
Act by section 226 of the Food and Drug Administration Amendments Act of
2007.
October
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.
ANNOUNCEMENTS:
The
Antibacterial Drug Development Task Force will assist in developing and
revising guidance related to antibacterial drug development, as
required by the Food and Drug Administration Safety and Innovation Act
(FDASIA), signed into law on July 9, 2012.
The
REMS Program Companies would like to make your organization aware of
grant funds available to support accredited independent continuing
education for the ER / LA class-wide opioid analgesics REMS.
UPCOMING MEETINGS:
Discuss
the humanitarian device exemption (HDE) application for the Argus II
Retinal Prosthesis System sponsored by Second Sight Medical Products,
Inc.
The
aim of the conference is to further the public health mission of the
FDA through training, collaboration, and structured discussion between
health professional organizations and FDA staff.
Discuss
the need for and design of clinical development programs necessary to
support approval of parenteral lipid emulsion products as nutritional
support.
Discuss
GATTEX (teduglutide) for subcutaneous injection, by NPS
Pharmaceuticals, Inc, for adult patients with short bowel syndrome
(SBS).
Discuss
lomitapide capsules, by Aegerion Pharmaceuticals, Inc., as an adjunct
to a low-fat diet and other lipid-lowering drugs in patients with
homozygous familial hypercholesterolemia.
Discuss
mipomersen injection, by Genzyme Corporation, as an adjunct to
maximally tolerated lipid-lowering medications and diet in patients with
homozygous familial hypercholesterolemia.
Discuss
a premarket approval application supplement to expand the indications
for use of the Selenia Dimensions 3D System with C-View Software Module,
sponsored by Hologic, Inc.
Discuss
the public health benefits and risks, including the potential for
abuse, of drugs containing hydrocodone either combined with other
analgesics or as an antitussive.
Discuss
biologics licensing application (BLA) 125346, raxibacumab injection, by
Human Genome Sciences, Inc. for the treatment of inhalational anthrax.
Discuss
new drug application (NDA) 204026, pomalidomide, by Celgene Corporation
for use with dexamethasone for patients with relapsed and refractory
multiple myeloma in the morning. Discuss supplemental New Drug
Application (sNDA) 021882/015, Exjade (deferasirox), by Novartis
Pharmaceutical Corporation for chronic iron overload in patients with
non-transfusion-dependent thalassemia syndromes in the afternoon.
Discuss
MSD Consumer Care, Inc., new drug application (NDA) 202211, for the
partial switch from prescription to over-the-counter (OTC) of the
oxybutynin transdermal system (proposed trade name OXYTROL FOR WOMEN)
for “overactive bladder in women.”
FDA's Clinical Investigator Training Course (Nov 13-15)
This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials.
Discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride, by Theravance, Inc., for nosocomial pneumonia.
A
presentation on pediatric provisions mandated by the Food and Drug
Administration Safety and Innovation Act. Information will be presented
regarding pediatric development plans for four products that are in
development for an adult oncology indication.
Please visit FDA’s Advisory Committee page (http://www.fda.gov/RESOURCES:
Interviews
Featuring
Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging
and Transfusion Transmitted Diseases, Center for Biologics Evaluation
and Research
Articles Please visit Articles of Interest (http://www.fda.gov/
Videos
MedWatch Safety Information Resources for Busy Physicians
http://www.youtube.com/watch?
A video discussing Medwatch Safety Alerts
Other Resources
Consumer Updates
Timely and easy-to-read articles covering all FDA activities and regulated products
The
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.
FDA Voice is the official blog from FDA's senior leadership and staff.
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.
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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