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 Issues
Food and Drug Administration