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FDA Updates for Health Professionals
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 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: HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall (Nov 19)HeartSine
notified customers that certain Samaritan 300/300P PAD devices have
been found to intermittently turn on and off, which may eventually
deplete the battery.
October Safety Labeling Changes (Nov 15)Safety Labeling Changes includes 58 products with revisions to Prescribing Information.
Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall (Nov 8)Baxter
Healthcare Corp. has initiated a voluntary recall of its Buretrol
Solution Sets because the ball-valve feature may not function as
expected.
Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: Safety Communication – Potential Risk of Infection (Nov 8)Advanced
Sterilization Products (ASP) is now recalling all lots of Sterrad
Cyclesure 24 Biological Indicators manufactured between February 2008
and December 2011.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch.PRODUCT APPROVALS:FDA approves first seasonal influenza vaccine manufactured using cell culture technology (Nov 20)FDA
announced the approval of Flucelvax, the first seasonal influenza
vaccine licensed in the United States produced using cultured animal
cells, instead of fertilized chicken eggs.
FDA approves pump for heart failure patients awaiting heart transplant (Nov 20)FDA
approved the HeartWare Ventricular Assist System, a left ventricular
assist device, to support heart function and blood flow in patients with
end-stage heart failure who are awaiting a heart transplant.
FDA approves first drug-eluting stent to treat peripheral arterial disease (Nov 15)FDA
approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX
Stent), the first drug-eluting stent indicated to re-open a particular
artery in the thigh when narrowed or blocked as a result of peripheral
artery disease.
For information on drug approvals, please visit Drugs@FDA OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for CommentsFDA
will be holding a public hearing to obtain input on how to address
microbial contamination of patient preoperative skin preparation drug
products.Comments will be accepted until February 12, 2013.
Establishing
a List of Qualifying Pathogens That Have the Potential To Pose a
Serious Threat to Public Health; Public Hearing; Request for CommentsFDA
is seeking input on establishing a list of qualifying pathogens (i.e.,
those that have the potential to pose a serious threat to public
health), as required under the Food and Drug Administration Safety and
Innovation Act. Submit comments by December 3, 2012.
Draft
Guidance for IRBs, Clinical Investigators, and Sponsors: IRB
Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the Determination of Whether an IND/IDE
Is NeededThe
draft guidance announced in this notice is intended to assist
institutional review boards, clinical investigators, and sponsors
involved in clinical investigations of FDA-regulated products in
fulfilling responsibilities related to reviewing the qualifications of
investigators, adequacy of research sites, and the determination of
whether an investigational new drug application or investigational
device exemption is needed in order to assure the protection of the
rights and welfare of human subjects in clinical investigations.
Comments due by January 22, 2013.
Guidance
for Industry - FDA and Industry Actions on Premarket Notification
510(k) Submissions: Effect on FDA Review Clock and GoalsThe
Medical Device User Fee Amendments of 2012 authorizes FDA to collect
user fees for the review of certain premarket submissions received on or
after October 1, 2012, including premarket notification submissions
(510(k)s).
Request for Comments: Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public WorkshopFDA
will be holding an open public hearing and workshop to further the
understanding of the development of disease-modifying agents for the
treatment of painful peripheral neuropathies. Comments for the open
public hearing due by February 1, 2013. Written comments due by March 1,
2013.
ANNOUNCEMENTS: Hernia Surgical Mesh Implants (Nov 16)FDA's
new webpage describes hernias, the different treatment options to
repair hernias and recommendations for patients that are considering
surgery for their hernias.
UPCOMING MEETINGS:
Anti-Infective Drugs Advisory Committee Meeting (Nov 28)The Committee will discuss bedquiline, an NME for the treatment of patients with multi-drug resistant tuberculosis.
Anti-Infective Drugs Advisory Committee Meeting (Nov 29)The
Committee will discuss VIBATIV (telavancin hydrochloride), a NME for
the treatment of hospital-acquired bacterial pneumonia.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (Dec 4)The
Subcommittee will be discussing issues relating to the development of
products for pediatric use and provide guidance to facilitate the
formulation of written requests for pediatric studies, if appropriate.
The four products under consideration are: (1) Trametinib, application
submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by
Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application
submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4)
blinatumomab (MT 103), application submitted by Amgen Inc.
Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Dec 5-6)The
Committee will discuss and make recommendations regarding the 515(i)
order issued by FDA on April 9, 2009 for the external counter-pulsating
(ECP) devices, intra-aortic balloon and control systems, and
nonroller-type cardiopulmonary bypass blood pumps, three of the
remaining pre-amendment class III devices.
Anesthetic and Analgesic Drug Products Advisory Committee Meeting (Dec 7)The
Committee will discuss the risks and benefits of proposed trade name
Zohydro ER (hydrocodone bitartrate extended-release capsules) for the
management of moderate to severe chronic pain when a continuous,
around-the-clock opioid analgesic is needed for an extended period of
time.
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Dec 10)The
Committee will discuss current knowledge about the safety and
effectiveness of the CoAxia NeuroFlo Catheter device for the intended
use of diverting cardiac output to the cerebral vasculature via partial
occlusion of the descending aorta, including in patients with acute
ischemic stroke within 14 hours of symptom onset.
Antiseptic Patient Preoperative Skin Preparation Products (Dec 12-13)FDA
is interested in obtaining public comment about certain scientific and
product use issues related to patient preoperative skin preparations.
Drug Safety and Risk Management Advisory Committee Meeting (Dec 12-13)On
December 12, the Committee will meet to discuss the various strategies
used by the Agency to define and address teratogenic risk, including
requiring REMS with ETASU. On December 13, the Committee will discuss
two common risk management tools used to minimize the risk of teratogens
– contraception and pregnancy testing.
Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health (Dec 18)This
public hearing is being held to obtain comments from the public to
determine the methodology that should be used in developing the list of
qualifying pathogens, and to elicit suggestions for adding specific
pathogens to the list.
Arthritis Advisory Committee Meeting (Dec 20)The
Committee will discuss rintatolimod injection (proposed trade name
AMPLIGEN) submitted by Hemispherx Biopharma, Inc. for the treatment of
patients with chronic fatigue syndrome.
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: FDA Basics Webinar: A Brief Overview of REMSThis
presentation will discuss REMS and how they are used to help ensure
that the benefits of certain medicines continue to outweigh their risks.
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products including:
- Medication Errors Happen to Pets, Too
FDA VoiceFDA Voice is the official blog from FDA's senior leadership and staff.
- Fighting Antibiotic Resistance
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.
Best regards, Office of Special Health IssuesFood and Drug Administration
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