#Prp law enforcement | Explore Tumblr Posts and Blogs

the-firebird69 · 3 years

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and the nyt said it but lke this you die and he got it wrong no said it backwards forwards and oh. now you say it and we say why...we become part of the grand army of the republic and try it...and fail no. we thinnk we succeed. and use it and then the empire is there right on it. and we try again...fail. and on earth and in the cold again. tons say it we use our stuff here to hit them...and we lost it to them again. then blew it up. huge huge lasers lost to infghting today..tons say it these rework it are brlllant inventors but not enginneers have better engineers and the best really..and wth his stuff the best and made better than him in a few instances...did too. the saber needed work, and he stopped found it too diffcult and we did it...and found the device and he remembers now. and tons do. good. we see. yeh we need it...get it. ours are grand but we need control yes. to enforce love andnot hate..law and to abide by it and very fairly. yes. and they try for our Empress of our Universe, and we defend her and with all we got we move into position they try for her shortly we have it sent it and they sent orders and we compile data...and he says anything we can bring to bear and shall. need it your huge huge beam on New Zealand and Australia would be nice it is larger...very huge but only 100 miles but huge very hot too. and we see..liimited use need to defend on earth but iin emergencies yes...and we prp then. we have new ships and lots with Lasers and we devote some yes to you Hera and decide now..he is there with hs huge ship and not in the way nope is off and hits from afar. tons see. and he calls Galactus for time. yes and she Galactica..and Galatius and Galacticus arrive and the others. to defend...tons do. we use it Zig Zag says...and heavy...tons of it firnig up all main reactors we are too Balaam Baal state all heat i see it. Thor a biuinchof us Olympus

https://www.youtube.com/watch?v=54CK8p-pDAU

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ynsespoir · 4 years

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Impending FDA Regulations for Regenerative Therapies

Regenerative Therapies – what does the future hold?

The Food and Drug Administration, or FDA, is responsible for monitoring almost all of the components related to human health. This includes medical equipment, medical procedures, medication, food, food processing equipment, and much more. Many of the products on the medical market today have been FDA approved. The approval process can take years, as it involves research and clinical trials. The field of regenerative medicine has seen a rapid increase in interest and practice recently due to constantly changing laws and FDA approval. The FDA website provides information about the current status of guidelines, as well as recommendations for best practices. Read on to learn about regulations that have already occurred, what they are doing present-day to regulate these therapies, and what the future holds.

Previous FDA Regulations and Laws

Current regenerative medicine practices include stem cell therapy, platelet-rich plasma (PRP) therapy, and gene therapy. These therapies seek to use a patient’s own cells to enhance healing properties that already exist naturally within the body. FDA regulations on these therapies are frequently changing, so they publish new information often.

In 2017, the FDA came out with four guidance documents regarding regenerative medicine. A guidance document is the FDA’s way of taking an official stance on a matter. These documents are used to provide a reference for the general public and industry professionals about what the future holds as well as regulatory techniques that could be used. Guidance documents are also used as a way for the FDA to provide recommendations for practices.

The content of a guidance document varies depending on the subject matter. Each document clearly states that the information is “nonbinding”, as these documents’ intended purpose is to guide industry professionals rather than enforce regulations. It should be noted, however, that FDA approval is much more likely to be obtained if these recommendations are followed.

The FDA has recently used a guidance document to announce a designation for regenerative therapy. Once certain criteria are met, treatment can be considered Regenerative Medicine Advanced Therapy (RMAT). Having the RMAT title could allow certain privileges such as a faster path to FDA approval. It is expressed that this title should be applied predominantly to the treatment of rare and serious conditions. Some of the criteria for achieving this designation include what the drug is being used for, if and how it has been tested, and the market’s need for the treatment. Creating this designation is important because it impacts the future of regenerative medicine in two important ways:

A Clear Path to FDA Approval: the process of obtaining FDA approval for regenerative medicine has been relatively unclear for years. Now that there is a clear plan, the public can become aware of treatments that may benefit them. This development also impacts clinics across the country; now that there is a more clear path to approval, clinics can begin or continue to practice accordingly.

Increased Access to Therapies: the FDA’s release of this designation means that there will be even more new research and clinical trials taking place in the near future. The more research is taking place, the more we are able to understand regenerative medicine. A greater understanding of regenerative medicine leads to more precise treatments and legitimacy. Increased research could also lead to new treatments and even cures for many diseases.

The public availability of these guidance documents is a crucial aspect of the process. FDA regulations are notoriously rigid, so providing practitioners with a clear-cut path to follow implies that the FDA is willing to begin acknowledging regenerative medicine as a legitimate form of medicine.

On December 13, 2016, the 21st Century Cures Act became law. The act sought to change the notoriously rigid FDA approval pathway. The goal of changing the approval process was to pave the way for new drugs and treatments to come to market more quickly. The field of regenerative medicine benefited greatly from this act, as many of the treatments and research in the field began to come to fruition. Clinics that have been researching regenerative medicine and performing clinical trials now have the opportunity to seek FDA approval much more quickly.

Current Classification of Medical Devices

Another guidance document that the FDA released in 2017 provided a more technical approach: the document contains recommendations for how equipment should be used. This document includes a reference to the classifications of medical devices and how these classifications are determined. All medical devices are divided into Class I, Class II, and Class III:

Class I: this classification refers to medical devices that present a low risk to the patient. These include everything from bandages to surgical trays.

Class II: moderate to high-risk medical devices. Some examples of Class II devices include acupuncture needles and motorized wheelchairs.

Class III: this classification poses the highest risk to patients. These devices include implantable pacemakers and implantable birth control, for example.

This is a useful document for practitioners of regenerative medicine, as it offers information about how to ensure that the equipment being used is compliant. Most medical devices fall under the Class II. In the field of regenerative medicine, much of the medical equipment that is being used has been FDA approved; however, it is worth noting that FDA approval is contingent on the intended use. For example, a surgical needle may be FDA approved, but not approved for the use of injecting stem cells or platelet-rich plasma. The intended use may also change the classification depending on the risk it poses.

What’s Next for Regenerative Medicine

On January 15th of 2019, the FDA released a statement by the commissioner and director of the Center for Biologics Evaluation and Research. The statement contained predictions of how long it will take to approve a certain number of regenerative therapies – stating that by 2020, there will be approximately 200 new therapies in the stages of receiving approval.

The statement also announced that the FDA plans to hire more employees who will be in charge of reviewing clinical trials, research, and new medical devices. This will allow regulations and approvals of regenerative therapies to move forward much more quickly. The FDA also plans to move forward with RMAT regulations in the hopes that more treatments can become approved soon. The statement also included the promise of certain new guidance documents, which will include recommendations for developing products.

The future of regenerative medicine is directly correlated to the FDA and its willingness to regulate the field. Thankfully, many regenerative medicines have already yielded positive results, so the FDA is doing what they can to provide an environment in which these practices can continue. The faster that the FDA can get regenerative medicine practices and products approved, the more likely it is that cures can be found and people with chronic pain or illness can be treated.

from Health Care Technology – ReferralMD https://ift.tt/2CVOHD6 via IFTTT Impending FDA Regulations for Regenerative Therapies Health Care Technology from topofbestone https://ift.tt/2XrQgSp via IFTTT

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topinforma · 7 years

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New Post has been published on Mortgage News

New Post has been published on http://bit.ly/2htlu7e

Businesses Need Asset Protection, Too

Affluent families and high-net-worth individuals have been using asset protection planning since the mid-1980s. Well, guess what? Businesses get sued, too. Yet, when you ask those in the C suite what they are doing to protect their company’s assets from lawsuits, you mostly get a blank stare.

SEE ALSO: Small-Business Owners’ Biggest Retirement Mistake

Small privately held businesses are often most at risk because litigation costs and expenses come out of the owner/executive pockets, not those of many multiples of shareholders.

Sometimes lawyers look to pile on a community of individual plaintiffs to scare the company into a settlement or face years of costly litigation and a drag on company morale.

The latest twist: so-called “Wage and Hour” disputes. A group of employees bands together, typically through the instigation of a plaintiff lawyer, who then sues the company about some issue surrounding the hours they worked and the wages they were paid.

These cases often start out small. But the plaintiff attorneys then contact many more employees, even past employees, to see if they want to join the “class.” Worse, many insurers are now excluding coverage for these sorts of claims.

What Can YOU Do to Protect Your Business?

If your company has substantial retained earnings and liquid assets, you might be able to create a foreign asset protection trust (FAPT) where the company is both the settlor and discretionary beneficiary of the trust. Absent a fraudulent transfer, once titled in the FAPT and subject to the more protective laws of the FAPT jurisdiction, a subsequent creditor won’t be able to enforce a judgment against the FAPT. This will discourage most lawsuits and encourage the parties to reach a settlement, generally far more favorable for the company than would have been the case had the FAPT not been created.

See Also: Which Career Path Are You On? Your Retirement Strategy Depends On It

Private Retirement Plan

In California, business owners can also create a Private Retirement Plan (PRP), a type of retirement savings plan that, by statutory law, is exempt from lawsuits, even if you have to file for bankruptcy. Qualified plans are generally exempt but require the business owner to comply with complex ERISA and tax laws.

The PRP may be set up as a non-ERISA qualified plan taking it outside of the regulatory scheme and thus, not subject to the more complex rules.

There are few limitations on the amount that may be contributed to non-ERISA qualified plans, because contributions are not income-tax-deductible, yet the statutory exemptions from creditor claims applies. This makes the PRP a useful tool to insure there will be supplemental retirement income for the employer.

More Options Companies Can Consider to Protect Their Assets

Leasing equipment, rather than owning it, reduces a company’s assets on its balance sheet.

Some corporations create separate companies for each brand that they own to reduce exposure.

Creating separate entities for the company’s intellectual property (IP) and then licensing them to the operating company so the IP is not owned by the target of a future lawsuit.

Distributing retained earnings to shareholders and stakeholders so the funds aren’t exposed to business liability. There’s also the option of having the company owned by a foreign asset protection trust so the distributions are not subject to personal liability.

One of the best ways to level the litigation playing field is to place the assets out of reach of future potential plaintiffs or convert non-exempt assets to exempt assets ahead of any future claim. Once this is done, your company won’t be so attractive to litigious plaintiff attorneys who only get paid if they recover assets from the judgments they obtain. Asset protection planning neutralizes this.

See Also: A Creative Way to Fund Your Entrepreneurial Passion: Your 401(k)

Jeffrey M. Verdon, Esq. is the managing partner of the Jeffrey M. Verdon Law Group, LLP, a Trusts & Estates boutique law firm located in Newport Beach, Calif. With more than 30 years of experience in designing and implementing comprehensive estate planning and asset protection structures, the law firm serves affluent families and successful business owners in solving their most complex and vexing estate tax, income tax, and asset protection goals and objectives.

Comments are suppressed in compliance with industry guidelines. Click here to learn more and read more articles from the author.

This article was written by and presents the views of our contributing adviser, not the Kiplinger editorial staff. You can check adviser records with the SEC or with FINRA.

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