July 17, 2013
PRODUCT SAFETY
Class I Recall: Medtronic MiniMed Paradigm Insulin Infusion Sets - Potential for Over or Under Delivery of Insulin
On June 7, 2013, Medtronic
sent an urgent medical device safety notification to healthcare professionals to
inform them of the potential for over or under delivery of insulin if insulin or
other fluids contact the inside of Medtronic Paradigm Tubing Connectors. More information
June 2013 Safety Labeling Changes
The
MedWatch June 2013 Safety Labeling Changes posting includes over 44 products
with safety labeling changes to the following sections: BOXED WARNINGS,
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE
INSERT. The
"Summary Page" provides a listing of product names and safety labeling sections
revised: More information
Class I Recall: Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5
and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades - Risk of
Blade Tip Breakage and Premature Failure
GlideScope GVL and AVL reusable blades were recalled
due to the potential risk of breakage and premature failure of the blade tip.
Device failure may not be readily visible during routine inspection before or
after insertion of the laryngoscope. This could result in pieces of the blade
breaking off in patients’ mouths and being swallowed or blocking the airway.
This product may cause serious adverse health consequences, including hypoxemia
(low blood oxygen), severe cuts to the airway leading to a significant loss of
blood, and/or death. More information
Recall: Estarylla (norgestimate and ethinyl estradiol) -
Report of Placebo Tablet Present in Row of Active Tablets
Sandoz
notified the public it is conducting a
voluntary nationwide recall to the retailer level of one lot of its
Estarylla
(norgestimate and ethinyl estradiol) tablets in the US, following a
customer
report of a placebo tablet present in a row of active tablets on one
pack. The lot number, expiration date, and NDC code of the recalled lot
is:
LF01213A, expiration date 02/2014, NDC 00781-4058-15. More information
Comunicaciones de la FDA sobre la
seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la
necesidad de proporcionar información sobre seguridad importante en idiomas
distintos al inglés. Hacemos lo mejor posible para proporcionar
versiones en español precisas y oportunas de nuestras Comunicaciones de
Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias
entre las versiones en ingles y en español, la información contenida en la versión
en inglés es la que se considera como versión oficial. Si tiene alguna
pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov.
Comunicaciones de la FDA
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch
PRODUCT APPROVALS AND CLEARANCES
FDA approves new treatment for a type of late-stage lung cancer
FDA approved Gilotrif (afatinib)
for patients with late stage (metastatic) non-small cell lung cancer (NSCLC)
whose tumors express specific types of epidermal growth factor receptor (EGFR)
gene mutations. Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a
companion diagnostic that helps determine if a patient’s lung cancer cells
express the EGFR mutations. More information
FDA permits marketing of first brain wave
test to help assess children and teens for
ADHD
FDA allowed marketing of the first
medical device based on brain function to help assess
attention-deficit/
hyperactivity disorder (ADHD) in children and
adolescents 6 to
17 years old. When used as part of a complete medical and psychological
examination, the device can help confirm an ADHD diagnosis or a
clinician’s
decision that further diagnostic testing should focus on ADHD or other
medical
or behavioral conditions that produce symptoms similar to ADHD. The
device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is
based on electroencephalogram (EEG) technology, which records different
kinds of
electrical impulses (waves) given off by neurons (nerve cells) in the
brain and
the number of times (frequency) the impulses are given off each second. More information
FDA permits marketing of quicker method for checking effectiveness of
medical device steam sterilization
FDA allowed marketing of the Verify Cronos Self Contained Biological Indicator
(SCBI), a new test that can help speed the determination of whether steam
sterilization of reusable medical devices is effective.The first biological indicator test that gives results in two hours, the
SCBI is used in reprocessing, a multistep process to clean and disinfect or
sterilize reusable medical devices. Properly reprocessed reusable medical
devices can be used safely for more than one patient. More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
OPPORTUNITIES FOR COMMENT / GUIDANCES
Request
for Comments: New Approaches to Antibacterial Drug Development
FDA is
seeking input from the public on the following topics related to antibacterial
drug development: Potential new study designs, proposed priorities for CDER
guidances, and strategies intended to slow the rate of emerging resistance to
antibacterial drugs. Submit electronic or written comments by July 30, 2013. More
information
Request
for Comments: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To
Be Known as Sunlamp Products
FDA is
proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from
class I (general controls) exempt from premarket notification to class II
(special controls) and subject to premarket notification, and to rename them
sunlamp products. Submit either electronic or written comments on this proposed
order by August 7, 2013. More
information
Request for Comments: Draft Guidance for Industry and Food and Drug Administration Staff on Dear
Health Care Provider Letters: Improving Communication of Important Safety
Information
This draft guidance provides recommendations on when to use a Dear Health Care
Provider (DHCP) Letter, the types of information to include in a DHCP letter,
how to organize that information, and formatting techniques to make the
information more accessible. The draft guidance is intended to improve the
quality of DHCP letters to make them more effective communication tools for new
information about marketed products. Comments are due by August 8, 2013. More information
Request
for Comments: Food and Drug Administration Safety and Innovation Act Title
VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration
of Commercial Importers and Good Importer Practices
FDA is
seeking public comment on how to implement the drug supply chain provisions
found in Title VII of the Food and Drug Administration Safety and Innovation Act
(FDASIA) of 2012. Under Title VII FDA is authorized to require that
importers submit information demonstrating that their drug complies with
applicable requirements of the Federal Food, Drug and Cosmetic Act before their
products can enter the U.S. In addition, commercial importers must register with
FDA and meet good importer practices. Comments are due by August 12,
2013. More
information
Request for Comments: Draft
Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and
Biologics: Availability
The
purpose of this draft guidance is to provide a single resource for information
on FDA's policies and procedures related to expedited drug development and
review programs. The following programs are intended to facilitate and expedite
development and review of new drugs to address unmet medical need in the
treatment of serious or life-threatening conditions (expedited programs): Fast
track designation, breakthrough therapy designation, accelerated approval, and
priority review designation. Comments are due by August 26, 2013. More
information
Request for Comments: Testing Communications on Medical Devices and Radiation-Emitting Products
This notice solicits comments on communication studies involving medical devices
and radiation-emitting products regulated by FDA. This information will be used
to explore concepts of interest and assist in the development and modification
of communication messages and campaigns to fulfill the Agency's mission to
protect the public health. Comments are due by September 09, 2013. More information
Request
for Comments: Establishment of a Public Docket for Comment on the Report Prepared Under
the Food and Drug Administration Safety and Innovation Act Section 1138
On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) into law.
Section 1138 of FDASIA requires that FDA review and modify, as necessary, the
FDA communication plan to inform and educate health care providers and patients
on the benefits and risks of medical products, with particular focus on
underrepresented subpopulations, including racial subgroups.Section 1138 of FDASIA requires that FDA shall publicly post the
communication plan on the Internet Web site of the Office of Minority Health of
FDA, and provide links to any other appropriate Internet Web site, and seek
public comment on the communication plan. Comments are due by September 9, 2013. More information
Request
for Comments: Administrative Detention of Drugs Intended for Human or Animal Use
FDA is proposing a regulation to implement administrative detention authority
with respect to drugs intended for human or animal use as authorized by
amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the
applicable regulation is finalized, FDA's administrative detention authority
with respect to drugs will allow FDA to better protect the integrity of the drug
supply chain. Comments are due by September 13, 2013. More information
Request
for Comments: Possible Role of Independent Third Parties in Industry-Sponsored
Tobacco Product Research
FDA is
establishing a public docket for interested parties to submit to FDA comments on
the Institute of Medicine’s (IOM) recommendation regarding third-party
governance of industry-sponsored tobacco product research. FDA is interested in
receiving information on whether some form of third-party governance should be
considered for other types of industry-sponsored tobacco product research,
including research to support premarket tobacco product applications and other
submissions to FDA, as well as research designed to contribute to general
knowledge regarding tobacco products. Comments are due by September 30, 2013. More
information
ANNOUNCEMENTS
Consumer Update:Safety Problems With Your Child's Medical Device?
As
technology provides more health care options, children are frequently
diagnosed or treated with one or more medical devices. If there are
problems that prevent the safe use of pediatric medical devices,
FDA wants to know about them. FDA wants caregivers to report problems or
concerns to help ensure that pediatric devices can be used safely and
deliver
the intended benefits. And the agency wants to hear about the problems
when they
happen, especially if they might jeopardize the safety or care of a
child. More information
Why FDA Proposes an ‘Action Level’ for Arsenic in Apple
Juice
FDA is acting to help ensure that consumers do not come in contact with apple juice that has
levels of inorganic arsenic that exceed 10 parts per billion. That’s the same
level that the Environmental Protection Agency (EPA) has set for drinking water,
which is consumed in much greater quantities. More information
BeSafeRx:
Know Your Online Pharmacy
FDA
BeSafeRx is a national campaign to raise awareness of the dangers of buying
prescription medicines from fake online pharmacies. This campaign provides the
resources to help consumers. More
Information
UPCOMING MEETINGS
FDA
advisory committee 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.
Meeting
of the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 18)
The
committee will discuss new drug application, sugammadex sodium injection, for
the proposed indications of routine reversal of moderate and deep neuromuscular
blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB
at three minutes after administration of rocuronium. More
information
Dental
Products Panel of the Medical Devices Advisory Committee Meeting (Jul 18)
The
committee will discuss and make recommendations on the proposed regulatory
classification for dental devices known as Endosseous Dental Implants
(Blade-form), one of the remaining preamendments Class III devices. More
information
Arthritis
Advisory Committee Meeting (Jul 22)
The
committee will discuss the Assessment of SpondyloArthritis international Society
classification criteria for axial spondyloarthritis and the implications of
using these criteria for drug approval. More
information
Public
Workshop: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk
Assessment During Drug Development Without the Thorough QT Study (Jul 23)
This
workshop will introduce for discussion a new nonclinical paradigm for assessing
TdP risk and explore the parameters for an appropriate, strong, nonclinical
proarrthymia screening method as an alternative to clinical Thorough QT studies.
The workshop is intended to provide a forum for stakeholders, including experts
and opinion leaders from academia, industry, and regulatory agencies in the
U.S., the European Union, Canada, and Asian countries, to discuss what a new
framework might look like, the benefits and limitations of the current
guidelines, and the importance of a uniform assay schema. More
information
Public
Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies
(Jul 25-26)
FDA is
announcing a 2-day public meeting to obtain input on issues and challenges
associated with the standardization and assessment of risk evaluation and
mitigation strategies (REMS) for drug and biological products. More
information
Public
Workshop: Clinical Development Programs for Opioid Conversion (Jul 29)
FDA is
announcing a public scientific workshop to address public health concerns
associated with the inclusion of equianalgesic opioid conversion tables in
opioid product labels. Discussion will focus on the available data supporting
the use of equianalgesic opioid conversion tables, problems associated with
their use, and strategies used in clinical practice to convert patients from one
opioid analgesic product to another. More
information
Battery-Powered
Medical Devices Workshop (Jul 30-31)
This
meeting is a way to better understand and address the potential challenges
related to the design/development, selection, purchase, use, and maintenance of
battery-powered medical devices. It’s also designed to initiate greater
collaboration among stakeholders to develop best practices, training, and
industry standards for battery-powered medical devices. More
information
Scientific
Workshop: Tobacco Product Analysis (Jul 30-31)
The
purpose of this scientific workshop is to obtain input on the chemical analysis
of tobacco products. The analyses of tobacco products include developing test
methods and evaluating method performance to ensure the results of the analyses
are reliable and accurate. This scientific workshop will focus on understanding
the testing of tobacco filler and smoke from cigarettes, roll-your-own (RYO)
tobacco, and smokeless tobacco products for specific chemicals. More
information
Nonprescription
Drugs Advisory Committee (Jul 31)
The
committee will discuss data submitted by sanofi-aventis U.S., LLC to support a
supplemental new drug application (sNDA) 20468/S-035, for the switch from
prescription to over-the-counter (OTC) of triamcinolone acetonide nasal spray.
The proposed OTC use is “temporarily relieves these symptoms of hay fever or
other upper respiratory allergies: Nasal congestion, runny nose, sneezing, itchy
nose.” The applicant proposes to label the product for OTC use in adults and
children. More
information
Cardiovascular
and Renal Drugs Advisory Committee (Aug 5)
The
committee will discuss new drug application 204441, tolvaptan tablets, for the
proposed indication of slowing kidney disease in adults at risk of rapidly
progressing autosomal dominant polycystic kidney disease. More
information
Cardiovascular
and Renal Drugs Advisory Committee (Aug 6)
The
committee will discuss new drug application (NDA) 204819, proposed trade name
ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals
Inc., for the treatment of: (1) Chronic thromboembolic pulmonary hypertension
World Health Organization (WHO) Group 4 to improve exercise capacity and WHO
functional class and (2) pulmonary arterial hypertension (WHO Group 1) to
improve exercise capacity, improve WHO functional class, and to delay clinical
worsening. More
information
Risk Communications Advisory Committee (Aug 16)
On August 16, 2013, the Committee will discuss how FDA can communicate more
effectively with health
care professionals and other stakeholders about the public health risks posed by
counterfeit and unapproved drugs, in addition to safe purchasing practices, and
how FDA can evaluate that communication and its impact. More information
Joint Meeting of the Gastroenterology-Urology Panel and the Radiological
Devices Panel of the Medical Devices Advisory Committee (Sept 9)
The joint committee, convened by the Office of the Commissioner, will discuss
current evide