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August 28, 2013
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 PRODUCT SAFETY
FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories
FDA is advising
pharmacies of concerns about the adequacy of testing performed by Front Range
Laboratories, Inc., in Loveland, Colo., a testing laboratory used by more than
100 pharmacies in 32 states, to verify quality, sterility, and expiration
dating. More information
Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination
Wellness Pharmacy, Inc. issues nationwide voluntary recall of certain sterile
products due to laboratory results indicating microbial contamination. If there
is microbial contamination in medications intended to be sterile, patients are at
risk of serious infections which may be life threatening. More information
JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products
to the user level due to concerns of sterility assurance following a recent
inspection by FDA of Front Range Laboratories of Loveland, Colorado, one of the
contract testing labs used by JCB. More information
Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance
Park Pharmacy & Compounding Center is voluntarily recalling two lots of
products Methylcobalamin 5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013
and Multitrace-5 Concentrate 10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013
for injection, to the consumer level. In a recent inspection, FDA investigators
observed that methods used by the laboratory to assess sterility may have
resulted in pharmacies receiving inaccurate laboratory test results. More information
All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
FDA
is reminding health care providers
about safety concerns with all sterile drug products made and
distributed by
NuVision Pharmacy of Dallas, Texas. Health care providers should not
administer any NuVision Pharmacy sterile
products to patients because the products’ sterility is not assured.
NuVision Pharmacy has repeatedly declined to recall its sterile
products. More information
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage
FDA has required the drug labels and Medication Guides for all fluoroquinolone
antibacterial drugs be updated to better describe the serious side effect of
peripheral neuropathy. More information
Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections
Specialty Compounding, LLC is voluntarily recalling all lots of sterile
medications within expiry. The recall was initiated after reports of bacterial infection affecting 15
patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional
and Corpus Christi Medical Center Bay Area, whose treatment included IV
infusions of calcium gluconate from Specialty Compounding. More information
Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper
Covidien announced that it has initiated a voluntary recall of certain lots of
Monoject prefill flush syringes. This recall is being conducted due to the risk
that a number of the syringes were filled with water but not subjected to the
autoclave sterilization process. More information
Ortiga: Public Notification - Contains Hidden Drug Ingredient
FDA is advising consumers not to purchase or
use Ortiga, an unapproved product promoted for a variety of health conditions
and sold on multiple websites, including Ebay, and in some retail stores. More information
Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients
Jack Rabbit Inc. announced that it is conducting a voluntary nationwide recall
of one lot of the company's dietary supplement product sold under the name Jack
Rabbit. FDA lab analysis of the product was found to contain Sildenafil and
Tadalafil, which are active ingredients of FDA-approved drugs for erectile
dysfunction, making Jack Rabbit an unapproved drug. More information
Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients
Herbal Give Care LLC is voluntarily recalling all lots of Esbelder man (30
capsules), Esbelder fem (30 capsules) and Esbelder siloutte (30 capsules) to the
consumer level. The products have been found to contain undeclared Sibutramine,
N-Desmethylsibutramine, and N-di-Desmethylsibutramine. More information
Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient
Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of
72HP, Evil Root and Pro Power Max at the consumer level. According to
representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly
been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the
active ingredient in an FDA-approved drug for erectile dysfunction (ED) and
sildenafil is not listed on the product labels. More information
 PRODUCT APPROVALS
OPPORTUNITIES FOR COMMENT / GUIDANCESSecure Supply Chain Pilot Program
FDA is announcing the start of
the Secure Supply Chain Pilot Program (SSCPP). The SSCPP is intended to assist
FDA in its efforts to prevent the importation of adulterated, misbranded, or
unapproved drugs by allowing the Agency to focus its resources on imported drugs
that fall outside the program and may pose risks. This notice outlines the eligibility requirements and the
process for applying for participation in the SSCPP. FDA will be accepting applications for participation in the SSCPP
beginning September 16, 2013, and continuing through December 31, 2013. More information
Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry
This
guidance document is intended to assist industry and FDA staff in identifying
and appropriately addressing specific considerations related to the
incorporation and integration of radio frequency (RF) wireless technology in
medical devices. This guidance discusses issues that may affect the safe and
effective use of medical devices that incorporate RF wireless technology,
including selection of wireless technology, quality of service, coexistence,
security, and electromagnetic compatibility, and provides recommendations for
information to be included in FDA premarket submissions for such devices. More
information
Reopening of Comment Period:Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research
FDA
requested public comment regarding patients' perspective on current approaches
to managing HIV, symptoms experienced because of HIV or its treatment, and
issues related to HIV cure research. FDA is reopening the comment period to
allow interested persons additional time to submit comments. Comments are due by
September 3, 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: Format and Content Requirements for Over-the-Counter Drug Product Labeling
This
notice solicits comments on the standardized format and content requirements for
the labeling of over-the-counter (OTC) drug products. Submit comments by
September 23, 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
 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.
 Public Workshop: Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis (Sept 5 & 6)
FDA's
Center for Drug Evaluation and Research in cosponsorship with the American
Association for the Study of Liver Diseases is announcing a 2-day public
workshop entitled “Trial Designs and Endpoints for Liver Disease Secondary to
Nonalcoholic fatty liver disease (NAFLD).” This workshop will provide a forum to discuss trial
design, including endpoints for clinical trials in NAFLD, to promote efficient
drug development in this area and thus improved treatments for patients. More
information
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee (Sept 9 & 10)
The
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to
discuss ethical issues in pediatric product development, including medical
counter measures, focusing on the concepts of minimal risk, disorder or
condition, and exposure of pediatric subjects to risks under 21
CFR 50.54. More
information
Circulatory System Devices Panel of the Medical Devices Advisory Committee(Sept 11 & 12)
The
committee will discuss and make recommendations regarding the proposed
classification of external cardiac compressor, external pacemaker pulse
generators, and membrane lung for long-term pulmonary support systems.
More
information
Oncologic Drugs Advisory Committee (Sept 12)
The
committee will discuss supplemental biologics license application
with the trade name PERJETA (pertuzumab) injection. The proposed indication for this product is in combination
with trastuzumab and docetaxel for the neoadjuvant treatment of patients with
human epidermal growth factor receptor 2 -positive, locally advanced,
inflammatory, or early stage breast cancer as part of a complete early breast cancer regimen containing either
fluorouracil, epirubicin, and cyclophosphamide or carboplatin.
More information
The Patient Preference Initiative: Incorporating Patient Preference Information Into the Medical Device Regulatory Processes: Public Workshop; Request for Comments (Sept 18 & 19)
The
purpose of the workshop is to discuss ways to incorporate patient preferences on
the benefit-risk tradeoffs of medical devices into the full spectrum of the
Center for Devices and Radiological Health regulatory decision making. It
also aims to advance the science of measuring treatment preferences of patients,
caregivers, and health care providers. More
information
Pediatric Advisory Committee (Sept 19 & 20)
The
Pediatric Advisory Committee will discuss pediatric-focused safety
reviews, as mandated by the Best Pharmaceuticals for Children Act and the for Pediatric Research Equity Act. More
information
Food Advisory Committee (Sept 23 & 24)
The Food
Advisory Committee will discuss detection signals for noteworthy
chemical hazards in foods, dietary supplements, and cosmetics and consider
possible sources of information, data on chemical hazards, and how CFSAN might
recognize and best take advantage of those data. More
information
Narcolepsy Public Meeting on Patient-Focused Drug Development (Sept 24)
The
public meeting is intended to allow FDA to obtain patients' perspectives on the
impact of narcolepsy on daily life as well as the available therapies for
narcolepsy. More
information
Great Lakes cGMP & Regulatory Science Forum (Sept 24-25)
This
2-day forum in Chicago, IL will feature experts from FDA, industry, and academia
who will discuss the current initiatives to enhance regulatory science,
pharmaceutical manufacturing and product quality.
More information
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology(Sept 25)
The
committee will discuss optimal strategies for the evaluation, interpretation,
and communication of drug-drug interaction (DDI) information. FDA will seek
input on: (1) Best practices in DDI communication through prescription drug
product labels, namely: (a) Appropriate format for
presentation of DDI information; (b) level of detail
of DDI study results; and (c) appropriate wording for clinical recommendations
based on empirical data versus anticipated interactions; (2) appropriate
criteria for determining whether or not to describe DDI information derived from
the literature in product labels; and (3) how package insert information on DDIs
is used by various end-users in decision making and/or communication. More
information
 Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop (Oct 7)
The
purpose of the public workshop is to bring together a broad range of
stakeholders to discuss current and future standards development activities
involving cellular therapies and regenerative medicine products. More
information
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Oct 16)
The
committee will discuss the supplemental new drug application, Vascepa
(icosapent ethyl) Capsules. This supplemental application proposes
concomitant use with an inhibitor of
HMG-CoA reductase to reduce triglycerides, non-high-density
lipoprotein cholesterol, apolipoprotein B, low-density
lipoprotein cholesterol, total cholesterol and very-low-density
lipoprotein cholesterol in adults with mixed dyslipidemia and coronary
heart disease (CHD) or a CHD risk equivalent. More information
Anti-Infective Drugs Advisory Committee Meeting (Oct 17)
The
purpose of the meeting is to discuss susceptibility interpretive criteria for
systemic antibacterial drugs and for dosing recommendations in product labeling.
We will seek input on the role of pharmacokinetic data in setting susceptibility
interpretive criteria. We will also discuss revising dosing recommendations in
product labeling based on pharmacokinetic data and clinical safety and efficacy
data.
More information
Anti-Infective Drugs Advisory Committee (Oct 18)
The
committee will discuss the safety and effectiveness of new drug application, miltefosine capsules, for
the proposed indication of treatment of patients with visceral, mucosal,
and cutaneous leishmaniasis, an infection caused by a
parasite. More
information
Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop (Oct 21 & 22)
FDA
Center for Drug Evaluation and Research, in cosponsorship with the American
College of Gastroenterology, the American Gastroenterological Association, the
Crohn's and Colitis Foundation of America, Inc., the North American Society for
Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD
Foundation, is announcing a 2-day public workshop entitled “Gastroenterology
Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).” Partners
and stakeholders planning the workshop also include patients and representatives
from the Eunice Kennedy Shriver National Institute of Child Health and Human
Development at the National Institutes of Health. More
information
Cellular, Tissue and Gene Therapies Advisory Committee (Oct 22 & 23)
The
Committee will discuss oocyte modification in assisted reproduction for the
prevention of transmission of mitochondrial disease or treatment of infertility.
The Committee will also hear updates on guidance documents issued from the
Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation
and Research, and discuss considerations for the design of early-phase
clinical trials of cellular and gene therapy products. More
information
 Third Annual Food and Drug Administration Health Professional Organizations Conference (Oct 24)
FDA is
announcing a conference for representatives of Health Professional
Organizations. Topics on the agenda include FDA Updates, an overview of FDA's
Network of Experts (public/private partnerships), and a FDA Town Hall. The FDA
Town Hall will feature FDA senior executives including Jeffrey Shuren, M.D.,
J.D., Director of the Center for Devices and Radiological Health; Douglas C.
Throckmorton, M.D., Deputy Director for Regulatory Programs of the Center for
Drug Evaluation and Research; and Michael R. Taylor, Deputy Commissioner for
Foods and Veterinary Medicine. More
information
 RESOURCES
Medical Product 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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International Journal for Equity in Health
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