[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather
Santa Clarita CA
Sunny
Sunny
63°F
 
Calendar
Today in
S.C.V. History
October 22
1898 - Birth of Mary S. Ruiz, eldest child of Enrique & Rosaria Ruiz of San Francisquito Canyon; all died in 1928 dam disaster [cemetery census]



Product Safety Bar

Drug Safety Caution SignEvil Root and Pro Power Max Due to Undeclared Sildenafil
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). More informationFDA investigating rare brain infection in patient taking Gilenya (fingolimod)
FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML. More information

Federal judge approves consent decree against Dakota Laboratories
Dakota Laboratories LLC and its president, Charles L. Voellinger, Sr., are prohibited from manufacturing and distributing drugs until they correct their ongoing violations of the drug manufacturing laws. The U.S. Food and Drug Administration entered into a consent decree of permanent injunction on Aug. 26, 2013 which enjoined the drug maker and distributor for repeated failure to comply with federal drug manufacturing requirements, known as Current Good Manufacturing Practices (cGMPs).  More information

 

Blue Shirt/ hand with finger pointing to rightComunicaciones 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
Medwatch 20th anniversary 

MedWatch: The FDA Safety Information and Adverse Event Reporting Program
For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.


Product Short and DC

Empty Medicine Cabinet with Empty Medicine BottleFDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information

 

Drug Shortages Resolved During the Past 2 Weeks:

 

  • Methoxsalen 1% Topical Lotion (Oxsoralen)
  • Sodium Benzoate
  • Sodium Phenylacetate (Ammonul) Injection

 

 

 

 

 

 

 

Blue Shirt/ hand with finger pointing to right

 


Product Approval Bar

No New Product Approvals.

 

Drugs@FDAFor information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

Comments and Guidances


View current opportunities for comment on topics of interest for patients.

 

Announcements Bar

Demystifying FDAPublic Meeting: FDA Patient Network Annual Meeting – Demystifying FDA: An Exploration of Drug Development
Date: September 10, 2013
This meeting will serve as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. More information
Michelle McMurry HeathConsidering Women’s Needs in Developing Medical Devices: Here’s ‘HoW’, by Michelle McMurry-Heath, MD, Ph.D.
Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do.That is why FDA is actively trying to learn more about how medical devices uniquely affect women, and how women can be better served by them.

This month we published a snapshot of how FDA is doing with such efforts. A congressionally-required report (Section 907 of the Food and Drug Administration Safety and Innovation Act) looked at the inclusion and analysis of women and other demographic subgroups in clinical studies supporting the approval of medical devices and other FDA-regulated medical products.

To read the rest of this blog, See FDA Voice Blog, August 30, 2013

 

 


New method could speed potency testing of influenza vaccines
Scientists at FDA have developed a method in their laboratory for quickly measuring the amount of hemagglutinin (HA) antigen in standards used for potency testing of seasonal and pandemic influenza vaccines.

Seasonal and pandemic influenza is a significant public health threat and vaccination is the cornerstone for the prevention of influenza and its related complications, which can be severe. A fast and more accurate alternative method to measure influenza vaccine antigen content would facilitate more rapid preparation of reference standards and support production and availability of seasonal as well as pandemic influenza vaccines. More information


Lynne YaoFDA takes step to encourage pediatric drug studies, by: Lynne Yao, M.D., Associate Director, Pediatric and Maternal Health Staff
We all know that children are not just small adults. Many changes occur in children as they grow and develop that can affect how a drug works. In fact, some drugs that work in adults may not work at all in children. There may be different safety concerns compared to when they are used by adults, or they may need to be given in a different dose. That’s why products that are used in children must be studied in children.Congress enacted two laws that will increase the study of drugs in children: The Best Pharmaceuticals for Children Act (BPCA) provides an incentive for drug companies to conduct FDA-requested pediatric studies by granting an additional six months of marketing exclusivity.

To read the rest of this blog, See FDA Voice Blog, August 26, 201

 


Ucoming Meetings Bar

Advisory Committee Meeting at FDA

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.

View a complete list of upcoming public meetings and workshops

 

 

 

Blue Shirt/ hand with finger pointing to rightPlease 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.

Consumer Update bar

Hyberbaric Oxygen TherapyHyperbaric Oxygen Therapy: Don’t Be Misled
No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you’ll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA. 

HBOT involves breathing oxygen in a pressurized chamber. The Food and Drug Administration (FDA) has cleared hyperbaric chambers for certain medical uses, such as treating decompression sickness suffered by divers.

 

HBOT has not, however, been proven to be the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health. To continue reading Consumer Updates article.


More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information

Artículos en Español
Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable.
Artículos en Español


Food Safety BarMythbusters

Food SafetyCenter for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics.
More information 

Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information


Animal Health Bar

CooperAnimal Drug Shortages
A drug shortage may involve either an actual or a potential shortage of a drug product. When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the U.S. and, when necessary, other countries, to find ways to resolve shortages of medically necessary veterinary products. FDA does not have the authority to require a company to make any product, even if it is medically necessary. More information
Dog with GlassesAnimal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information 

 

CVM Pet Facts
The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information


Resources

Janet WoodcockHave a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won’t be able to answer each question in this format. We may edit your questions for brevity or clarity. More information 

 

To read questions and answers, see MailBag.

FDA On line ResourceFDA Basics
Each month, different centers and offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More informationEducational Videos
FDA Food Safety and Modernization Act: An FDA Primer
The Rulemaking Process: An FDA Primer
What is Regulatory Science
Taking Acetaminophen Safely

 

healthfinder.govhealthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information 

Tobacco Products Resources for You
Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics.
More information

 

 

 

 

 


Take me to the web site

An interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­– and medical devices move from the realm of idea to the realm of the marketplace. More information


PNN Footer

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


SCV NewsBreak
Loading...
LOCAL NEWS HEADLINES
Sunday, Oct 22, 2017
OutWest Owners Jim and Bobbi Jean Bell Ride East Into the Sunrise
Bobbi Jean and her husband Jim Bell, whose OutWest clothing store and popular TV concert series celebrated all things Western and equestrian and helped revitalize Old Town Newhall over the past decade, will soon ride east into the sunrise: They’re moving to New Mexico.
Friday, Oct 20, 2017
Heat Alert for SCV, L.A. County on Monday, Tuesday
The Los Angeles County Health Officer has issued a heat alert as high temperatures have been forecast for the Los Angeles Basin on Monday, October 23 through Tuesday, October 24.
Friday, Oct 20, 2017
Nearly $3.4 Billion in Transportation Projects to Be Accelerated
Caltrans added nearly 1,200 lane miles of pavement repair and 66 bridges to its growing list of projects to be delivered sooner than planned, thanks to the imminent influx of revenue from the Road Repair and Accountability Act of 2017 (SB 1), the transportation funding and reform package passed in April.
Keep Up With Our Facebook

Latest Additions to SCVNews.com
Bobbi Jean and her husband Jim Bell, whose OutWest clothing store and popular TV concert series celebrated all things Western and equestrian and helped revitalize Old Town Newhall over the past decade, will soon ride east into the sunrise: They’re moving to New Mexico.
OutWest Owners Jim and Bobbi Jean Bell Ride East Into the Sunrise
1898 - Birth of Mary S. Ruiz, eldest child of Enrique & Rosaria Ruiz of San Francisquito Canyon; all died in 1928 dam disaster [cemetery census]
2007 - Buckweed fire chars 38,000 acres, destroys 21 homes in Canyon Country and Agua Dulce [story]
Tonight on SCV NewsBreak, a sexual assault suspect was arrested Thursday night. Plus, some great weekend events. Watch these stories and more on tonight's edition of SCV NewsBreak.
SCV NewsBreak for Friday, October 20, 2017
Forever Fit SCV, a Santa Clarita sports and personal fitness training company, will host a "Pumpkin Workout" at its Centre Pointe location on Saturday, October 28, starting at 9 a.m.
Oct. 25: Pumpkin Workout Benefits American Cancer Society
The next regular meeting of the Governing Board of the William S. Hart Union High School District is set for Wednesday, Oct. 25 at 7 p.m.
Oct. 25: Hart School District Governing Board Meeting
The LA County Public Defender has won the Silver Eagle Award for its Public Defender Jail Liaison Program during the 31st Annual Productivity and Quality Awards Ceremony on Oct. 18 at the Dorothy Chandler Pavilion.
LA County Public Defender Soars with Silver Eagle Award
The Los Angeles County Health Officer has issued a heat alert as high temperatures have been forecast for the Los Angeles Basin on Monday, October 23 through Tuesday, October 24.
Heat Alert for SCV, L.A. County on Monday, Tuesday
The Academy Museum of Motion Pictures has received three major gifts toward the creation of the museum in Los Angeles, bringing fundraising to more than $300M, nearly 80 percent of its $388M campaign goal.
Motion Picture Museum Nears $388M Campaign Goal
Caltrans added nearly 1,200 lane miles of pavement repair and 66 bridges to its growing list of projects to be delivered sooner than planned, thanks to the imminent influx of revenue from the Road Repair and Accountability Act of 2017 (SB 1), the transportation funding and reform package passed in April.
Nearly $3.4 Billion in Transportation Projects to Be Accelerated
The city of Santa Clarita and SCV Veterans Memorial, Inc. invite the public to attend a special ceremony unveiling the new Fallen Warriors Monument at Veterans Historical Plaza in Newhall on Wednesday, November 8 starting at 10 a.m.
Nov. 8: City Unveils Fallen Warriors Monument in Newhall
Crime Prevention deputies from the Santa Clarita Valley Sheriff's Station along with Los Angeles County Probation Department officers conducted probation compliance searches Friday throughout the Santa Clarita Valley.
SCV Deputies Check Probationers, Aid in Domestic Violence Call
Here is the Santa Clarita Valley Sheriff Station's public safety report for Canyon Country (West), aka Zone 7, for October 2 through October 8, 2017
Crime Blotter: Robbery, Grand Theft in Canyon Country West
A suspect has been arrested in the investigation of an alleged sexual assault, according to Santa Clarita Valley Sheriff's Station officials.
Suspect Arrested in Alleged Sexual Assault
Motor vehicle collisions are the leading cause of death for teens in the United States and a concern the California Highway Patrol addresses with its "Start Smart" program.
CHP Helps New Drivers with ‘Start Smart’ Classes
The California High-Speed Rail Authority punted one of the most important decisions during its monthly meeting Thursday, stoking concerns the entity is not moving quickly enough on the $64 billion project.
California’s Bullet Train Board Delays Award of Key Contract
An extensive investigation by the county of Los Angeles Department of Consumer and Business Affairs in conjunction with the office of California Attorney General Xavier Becerra has resulted in a lawsuit announced today by the Attorney General against retailer Curacao.
AG Sues Retailer Curacao for Allegedly Preying on Consumers
1873 - Santa Barbara lawyers Charles Fernald and J.T. Richards purchase Rancho San Francisco for $33,000 (75 cents an acre) in a sheriff's sale [story]
CHESTERFIELD, MO — NewGround, a St. Louis-based experiential design-build firm, recently teamed up with Logix Federal Credit Union to work on a large scale facility project, a new corporate headquarters building for the full-service credit union in the Burbank, California area.
Valencia Will Soon be Home to Logix Federal Credit Union Headquarters
The CSUN women's volleyball team (10-9, 4-3 Big West) opens the second half of the Big West season this week as the Matadors head up the coast this week for road tests at No. 23 Cal Poly (17-2, 7-0 Big West) and UC Santa Barbara (4-15, 3-4 Big West). CSUN, coming off a tough five-set loss to Hawai'i at home, is 3-4 in seven road matches this season but has won two of three Big West road contests.
Matadors Volleyball Testing Their Skills on the Road
No. 5 College of the Canyons defeated L.A. Mission College 3-0 on Wednesday to earn its eighth consecutive match and fifth straight sweep. Set scores were 25-15, 25-11, and 25-20.
Cougars Volleyball Earns Fifth Straight Sweep
CSUN Women's Soccer (7-4-5, 3-1-1 BWC) looks to move up in the Big West standings this week as it hosts UC Irvine on Thursday at 7:00 p.m.
Matadors Get Ready for Big West Matchups
Behind Julio Rubio's goal in the 11th minute CSUN defeated UC Riverside 1-0 in Big West Conference men's soccer action Wednesday night.
Matadors’ Lone Goal Enough to Hold Off UC Riverside
Northridge, CA – CSUN Athletics officially opened its new satellite athletic training facility on Thursday at an event featuring Athletic Director Dr. Brandon Martin, Assistant Athletic Director for Sports Medicine/Head Athletic Trainer Steven Grech, student-athletes, coaches, staff and campus partners.
Matadors Student-Athletes Welcome New Training Facility
Want unique gifts and a shopping experience unlike any other?
Nov. 18-19: City’s Annual Two-Day Fine Craft Show
City officials gathered Wednesday for the Grand Opening of "Three Oaks," the first 100 percent affordable family development in Santa Clarita.
Affordable Housing Comes to Santa Clarita
The Gibbon Conservation Center will celebrate Halloween for the first time on Saturday, Oct. 28 from 10:00 a.m. - 1:00 p.m.
Oct. 28: Gibbon Conservation Center Celebrates First Halloween
California State University, Northridge is partnering with the California State University Entertainment Alliance to host a morning of workshops designed to offer students and members of the public advice on building successful careers in the entertainment industry.
Oct. 23: CSUN Workshop; Succeeding in Entertainment Industry
Spotlight Arts Center, a local non-profit that provides free performing and visual arts classes to children in the Santa Clarita Valley, will hold its Fall Festival, Sunday, Oct. 22 from 11:00 a.m. - 3:00 p.m.
Oct. 22: Fall Festival Spotlight Arts Center
The College of the Canyons Athletics department is inviting all players, coaches and cheerleaders associated with a Santa Clarita Valley youth sports league or cheer organization to attend Saturday's Cougar football game free of charge.
Oct. 21: SCV Youth Teams Invited to Free COC Football Game
College of the Canyons freshmen Joanna Roecker and Cassandra Lee both turned in scores of 79 to lead the Cougars to a second place team finish at the Western State Conference (WSC) event hosted by Glendale College at Brookside Golf Course on Monday.
COC Falls Short at WSC Glendale
Beginning Monday, October 23, 2017, the city of Santa Clarita will increase the frequency of street sweeping throughout all areas of the City.
Oct. 23: City Begins Increased Street Sweeping Frequency
In a battle for Western State Conference, East Division supremacy, it was College of the Canyons that came out on top Tuesday night, as the Cougars scored two second half goals to secure a 2-0 win against visiting Antelope Valley College. Justine Hoeft and Jennifer Roney collected goals for the Cougars (11-2, 2-0).
COC Secures Win Against AVC With Two Second-Half Goals
The upcoming 10-year anniversary of the Buckweed Fires offers Santa Clarita residents a reminder of the ever-present fire danger in Los Angeles County, as blazes ravage the northern half of the state, as well.
Officials Reflect on 10-Year Anniversary of Buckweed Fires
Deputies from the Santa Clarita Valley Sheriff's Station, with help from a Smartphone GPS system, were able to locate a lost hiker Wednesday night at Towsley Canyon.
Smartphone GPS Locates Lost Towsley Canyon Hiker