FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions Arizona company claims their products can treat Lyme disease, diabetes, Parkinson’s disease and more, but have not been approved for any use
Español
The U.S. Food and Drug Administration has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona, and its chief executive officer, David Greene, M.D. The company, through its affiliated centers or clinics throughout the U.S., offers unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS). The products offered by R3 Stem Cell, LLC are not approved by the FDA.
The FDA has notified each of R3 Stem Cell, LLC’s more than 50 affiliate centers or clinics of this action.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products. The reality is that at this time, there isn’t enough evidence to support the use of stem cells for purposes other than reconstitution of blood formation and the immune system,” said FDA Acting Commissioner Ned Sharpless, M.D. “We’ve made it clear to the industry and the public that while we are taking a risk-based approach to regulatory actions, the FDA will continue to protect patients from the most egregious actors in this field. We will prioritize appropriate regulatory actions against those who place people’s health at risk by promoting unapproved products.”
In the FDA’s review of the R3 Stem Cell, LLC website, the agency found that the company promotes stem cell therapies for numerous diseases or conditions, such as dementia and Parkinson’s disease, and directs patients with ALS, diabetes, kidney failure, Lyme disease, Parkinson’s disease and stroke to certain “R3 Stem Cell Centers of Excellence” for stem cell treatment. The untitled letter notes that the company advertises that a variety of other conditions can be treated at R3 Stem Cell Clinics, including rheumatoid arthritis, spinal stenosis, and trigeminal neuralgia (nerve pain).
It appears that the products offered by the company would be regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act and the Public Health Service Act. Prior to marketing, such products require a demonstration that the products are safe and effective for their intended uses. Manufacturers who fail to comply with FDA requirements may be subject to enforcement action, such as seizure, injunction, or prosecution.
“We encourage firms to engage with the FDA about regulatory oversight of this field and work with the agency for appropriate development, including designing clinical trials, to explore the safety and potential benefits of these products. We intend to step up our oversight of those sponsors who have not engaged the regulatory process in the proper development of their stem cell products that are regulated as drugs, devices, and/or biological products under the statutes and existing regulations, and whose products create more significant potential risks because of the way that they’re manipulated or delivered,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Over the past year, the FDA has sent 46 manufacturers and health care professionals regulatory correspondence, including today’s untitled letter. We have also sent warning letters, and we have two court cases pending. We’re committed to taking appropriate steps to address those that jeopardize public health.”
As highlighted in 2017 with the release of the FDA’s comprehensive regenerative medicine policy framework , the FDA is applying a risk-based regulatory approach to the oversight of regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended. The agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to the FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns.
The FDA offers opportunities for engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as discussed in a New England Journal of Medicine perspective authored by the FDA.
Health care professionals and consumers should report any adverse events related to treatments with R3 Stem Cell, LLC products and/or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form . The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace. ###
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ###

Read More…

(USA-CA-Ontario) Associate Intern (Los Angeles, CA)

CBRE Associate Intern (Los Angeles, CA) in Ontario , California
Associate Intern (Los Angeles, CA)
Los Angeles, California, United States at https://cbre.referrals.selectminds.com/jobs/60735/other-jobs-matching/location-only
New
5 additional locations
Ontario, California, United States Newport Beach, California, United States Glendale, California, United States El Segundo, California, United States Beverly Hills, California, United States
Sales/Brokerage at http://cbre.referrals.selectminds.com/landingpages/salesbrokerage-8
3 hours agoPost Date
About CBRE
With broader and deeper capabilities than any other company, CBRE is the leading full-service real estate services and investment organization in the world. A CBRE internship gives you a unique opportunity to get a head start in the commercial real estate industry by working alongside some of our top producing professionals. Our associates will gain valuable real-life experience and learn the business by working on CBRE projects.
CBRE Group, Inc. is the world’s largest commercial real estate services and investment firm, with 2018 revenues of $21.3 billion and more than 90,000 employees (excluding affiliates). CBRE has been included in the Fortune 500 since 2008, ranking #146 in 2019. It also has been voted the industry’s top brand by the Lipsey Company for 18 consecutive years, and has been named one of Fortune’s “Most Admired Companies” in the real estate sector for seven years in a row. Its shares trade on the New York Stock Exchange under the symbol “CBRE”.
The Company serves real estate investors and occupiers through approximately 480+ offices worldwide (excluding affiliates). CBRE offers a broad range of integrated services, including facilities, transaction and project management; property management; investment management; appraisal and valuation; property leasing; strategic consulting; property sales; mortgage services and development services.
About the Internship Program
The CBRE National Sales Internship accelerates your learning and development by providing you with a strong foundation upon which to build your commercial real estate sales career. This eight-week summer intern program will introduce you to our company, our fast-paced industry, and your world-class professionals. Program participants will receive real-world training and participate in networking and learning opportunities.
The summer internship will begin in June 2020 and end in August 2020.
Responsibilities
Conduct company, property and industry-specific research
Manage and update prospects in an internal tracking database
Assist in developing and preparing marketing and presentation materials
Track local and regional activity, e.g., economy, employment statistics, major company activity, industry trends and demographics that affect the local real estate market
Contribute to special projects in support of business development
Provide ongoing support with current deals, including market surveys, proposal reviews and summaries, lease reviews, financial analysis
Qualifications
The internship is designed for results-oriented and entrepreneurial candidates with a strong academic background, preferably in business or real estate. Applicants should be self-motivated, creative, disciplined ad exhibit a demonstrated interest in the commercial real estate industry.
Current college junior, senior, or graduate level student
Desire to work in the commercial real estate industry
Experience with MS Office with preferred experience in Salesforce and Tableau
Strong presentation skills
Ability to network and develop strong relationships
Detail-oriented and highly organized
Strong analytical and problem-solving skills
Solid written and oral communication skills
Ability to work independently and collaboratively
Work authorization
Application Process
We are accepting applications now and will begin our formal selection process for the internship program in January 2020. Qualified applicants will be contacted in February 2020 if they have been selected to move forward in our process.
To be considered for a position with CBRE, please apply online at http://cbre.com/careers. Click on “Search and Apply” on the left side of the screen. If a pop-up window does not open, please check your browser’s settings. On the login window either login with your existing username and password or click on “Register Today” to create one. Once you are logged in you can either apply for specific jobs or submit your general application using the link at the bottom of the page.
CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, martial status, disability, veteran status, political belief, or any other basis.
At this time, CBRE will not sponsor a new applicant for employment authorization for this position.
US Company Profile
About CBRE (NYSE: CBRE): At CBRE, you are empowered to take your career path into your own hands. Enjoy workplace flexibility in a global organization with tremendous scale. Work in an inclusive and collaborative environment with supportive teammates. Come experience the employee advantage at CBRE.
CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
As a Fortune 500 worldwide leader in real estate services, CBRE’s more than 90,000 professionals provide exceptional outcomes for clients in over approximately 480 offices worldwide. When it comes to real estate, CBRE sees potential everywhere. We turn scale into strength, expense into performance, and property into prosperity. Visit cbre.us.

Read More…

Leave a Reply