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FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices

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On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device Identification (UDI) system, finalizing the proposal first announced in July 2012. Our previous report of the proposed rule may be accessed here. In particular, the final rule will require that most medical devices distributed in the United States, with certain exceptions, bear a unique device identification on device labeling. It is also applicable to certain combination products that contain devices and to devices licensed under the Public Health Service Act. You can read the announcement here. Section 519(f) of the…
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FDA’s CFSAN Announces Plan for Program Priorities

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On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory center in the U.S. Food and Drug Administration (FDA), published its 2013-2014 Plan for Program Priorities. The plan outlines certain goals and objectives that CFSAN intends to achieve to improve food and cosmetic safety. You can read the 2013-2014 Plan for Program Priorities on the FDA’s website, available here. More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best…
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FDA Approves Botox Cosmetic for New Intended Use

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On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered via intramuscular injection. You can read the announcement here. The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA…
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Can a Florida Homeowner Enforce a Pooling and Servicing Agreement in a Foreclosure Suit?

Business, Real Estate Litigation , ,
[vc_column_text disable_pattern="true" align="left" margin_bottom="0" p_margin_bottom="20" width="1/1" el_position="first last"] [mk_dropcaps content="A" style="fancy-style" width="1/1" el_position="first last"]s many have heard, mortgages in today's market are not as simple as they once were.  It used to be the case that if you borrowed money from a bank, you can expect that this same bank owns the loan and will continue to be the point of contact you deal with through the life of the loan.  Unfortunately, that is not the case anymore. The Banks Nowadays, banks have found an interesting way to make even more money off your loan.  Instead of keeping the loan,…
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Business Transaction Litigation

Business , ,
[vc_column_text disable_pattern="true" align="left" margin_bottom="0" p_margin_bottom="20" width="1/1" el_position="first last"] [mk_dropcaps content="A" style="fancy-style" width="1/1" el_position="first last"]t Shehadeh Giannamore, PLLC, we provide quality services for the South Florida community of business clients. Whether you are starting your own business or wish to revise or create agreements for an existing company, we will make a successful transaction a reality. Complicated business matters often require the backing of an experienced lawyer. Our lead attorney Jay Shehadeh is the perfect representative in these aspects due to his background; he was raised in a family full of entrepreneurs. Mr. Shehadeh has developed a strong understanding of what…
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