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February 13, 2013
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 PRODUCT SAFETY
St. Jude Medical, AMPLATZER TorqVue FX Delivery System: Class I Recall - Core Wire May Fracture
FDA notified healthcare professionals of a Class I recall of the St. Jude
Medical, AMPLATZER TorqVue FX Delivery System. In a small number of cases, the
distal end of the core wire of the TorqVue FX Delivery System could potentially
fracture when exposed to a combination of certain cardiac anatomies and usage
conditions. More information
Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk
R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of
its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens
which are not declared on the labels of individual packets of the product. More information
Safety Labeling Changes: January 2013
The summary view includes drug products with safety labeling changes to
the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS,
or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. More information
 PRODUCT APPROVALS
FDA Approves Pomalyst for Advanced Multiple Myeloma
FDA approved Pomalyst (pomalidomide)
to treat patients with multiple myeloma whose disease progressed after being
treated with other cancer drugs. More information
FDA Approval of Generic Version of Cancer Drug Doxil is Expected to Help Resolve Shortage
FDA approved the first
generic version of the
cancer drug Doxil (doxorubicin hydrochloride liposome injection).
Doxil is currently on FDA’s
drug
shortage list. For products on the shortage list, the FDA’s Office of
Generic
Drugs is using a priority review system to expedite the review of
generic
applications to help alleviate shortages. More information
OPPORTUNITIES FOR COMMENT / GUIDANCESFood and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments
To
assist FDA in drafting a strategic plan on drug shortages as required
by the Food and Drug Administration Safety and Innovation Act, the
Agency is seeking public comment from interested persons on certain
questions related to drug and biological product shortages. Comments are
due by March 14, 2013. More information
Request for Comments: Draft Guidance for Industry and FDA Staff - Design Considerations for Devices Intended for Home Use
FDA is
announcing the availability of the draft guidance entitled “Design
Considerations for Devices Intended for Home Use.” This document is intended to
assist manufacturers in designing and developing home use medical devices that
comply with applicable standards of safety and effectiveness and other
regulatory requirements. Home use devices are associated with unique risks
created by the interactions among the user (often a layperson), the use
environment, and the device. This document identifies several factors that
manufacturers should consider, especially during device design and development,
and provides recommendations for reducing or minimizing these unique risks.
Comments are due by March 13, 2013. More
information
Request for Comment: Smokeless Tobacco Product Warning Statement
FDA
is establishing a public docket to obtain comments, supported by scientific
evidence, regarding what changes to the smokeless tobacco product warnings, if
any, would promote greater public understanding of the risks associated with the
use of smokeless tobacco products. Comments are due by April 1, 2013. More
information
Request for Comments: Impact of Approved Drug Labeling on Chronic Opioid Therapy
FDA invites comments on the public
health benefits and risks, including the potential for abuse, of drugs
containing hydrocodone either combined with other analgesics or as an
antitussive. Over the past several years, the role of opioid drugs in treating
chronic pain has been an increasingly common subject of public discussion. FDA
and other policymakers have been at the forefront of these debates, striving to
find a balance between minimizing opioid drug abuse and misuse, while
simultaneously enabling appropriate access to pain-relieving drugs. Comments are
due by April 8, 2013. More
information
ANNOUNCEMENTS
FDA Commissioner Margaret A. Hamburg’s Statement on the Institute of Medicine’s Report “Countering the Problem of Falsified and Substandard Drugs”
FDA commends the Institute of Medicine
for its thorough discussion and recommendations outlined in its report,
“Countering the Problem of Falsified and Substandard
Drugs.”
The report identifies causes and public health consequences of substandard
and falsified drugs and recommends a range of strategies to address the problem
and to promote global dialogue and action. More information
The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices
February is American Heart Month, and FDA has
a tool to help you achieve a heart-healthy lifestyle. More information
Federal Judge Approves Consent Decree with Ben Venue Laboratories
FDA announced that a federal judge has approved a
consent decree of permanent injunction against Ben Venue Laboratories, Inc., and
three of its corporate officers for failing to comply with current good
manufacturing practice requirements as required by federal law. More information
Safe Use Initiative: Acetaminophen Toxicity
Under
the leadership of the National Council for Prescription Drug Programs
(NCPDP), FDA’s Safe Use Initiative and a broad group of stakeholders
came
together in 2011 to form the Acetaminophen Best Practices Task Group,
which
produced Version 1.0 of a White Paper and an update in January 2013,
Version 1.1. "NCPDP Recommendations for Improved Prescription Container
Labels for Medicines Containing Acetaminophen, Version 1.1" More information
Webinar: Introduction to Post-marketing Drug Safety Surveillance (Feb 26)
The webinar will give an overview of pharmacovigilance: the science and activities relating
to the detection, assessment, understanding, and prevention of adverse effects
or other drug-related problems. This is part 2 of a two part webinar
series concerning drug safety. Part 1 was held on January
29, 2013, “Introduction to
FDA's MedWatch Adverse Reporting Program”. The slides and presentation have been
archived and are available for viewing. More information
Webinar: Improved Access to Device Information: What a UDI System can do for Patients and Consumers (Feb 26)
Successful Unique Device Identification (UDI) implementation offers a number of
potential benefits for patients and consumers, including faster detection of
safety concerns associated with specific devices, more efficient communication
between providers and patients regarding important medical device information,
and independent patient access to information regarding their devices. More information
Webinar: State of Women's Heart Health
The webinar co-sponsored by The American Heart Association’s (AHA) Go Red For Women and Women
Heart: The National Coalition for Women with Heart Disease, featuring remarks by
HHS Secretary Kathleen Sebelius, FDA Commissioner Hamburg and representatives
from AHA and the Million Hearts Initiative discussing
advances in women’s health and actions you can take to reduce risk factors.
Register to listen to the archived webinar. More information
Consumer Update: Searching Online for 'Hemorrhoids'?
Whether you consider them a fit topic for conversation or not, it’s evident that
Americans want information about hemorrhoids. In 2012, more people searched
Google for information on hemorrhoids than on any other health topic. More information
Consumer Update: FDA: Foods Must Contain What Label Says
As someone who cares about what your family eats, you make it a practice when
shopping to read the labels on food packages. More information
Consumer Update: Beware of Fraudulent Flu Products
As the flu continues to make people sick—and even cause deaths—scammers are
alive and well, promoting their fraudulent products to the unsuspecting
public. More information
 UPCOMING MEETINGS
FDA
advisory committe meetings are free and open to the public. No prior
registration is required to attend. Interested persons may present
data, information, or views, orally at the meeting, or in writing, on
issues pending before the committee.
Other
types of meetings listed may require prior registration and fees.
Click on "more information" for details about each meeting.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
RESOURCES
Medical Prouct Safety Network (Medsun)
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 newsletter provides monthly updates about timely medical device
issues that may impact patient safety. More information
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