Tag Archives: Regulatory

RAPS Releases New Edition of Important US Regulatory Affairs Reference Book

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Rockville, MD, USA (PRWEB) July 02, 2013

The Regulatory Affairs Specialists Society (RAPS) has published the updated, eighth edition of its crucial regulatory reference book, Fundamentals of US Regulatory Affairs. The book provides extensive data on existing regulatory needs from the US Meals and Drug Administration (FDA), and other state and federal agencies.

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Fundamentals of US Regulatory Affairs, Eighth Edition includes updated regulatory information pertaining to pharmaceuticals, health-related devices, biologics and other healthcare items intended for the US market place. New content for this edition involves coverage of the Meals and Drug Administration Safety and Innovation Act (FDASIA) of 2012, and new chapters on pharmacovigilance, medical foods, crisis management, health technology assessment, and companion diagnostics. A chapter on Prescription Drug Product Submissions was revised by reviewers from FDAs Center for Drug Evaluation and Study, and is publicly accessible online.

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This book is an outstanding overview of the drug, biologic and device regulatory pathways and needs. It is thorough and clearly written, mentioned Edward Tabor, MD, vice president, regulatory affairs North America, Fresenius Kabi, and a member of RAPS board of directors. Not only is it beneficial for any individual who wants to learn about the regulatory method it also gives a prepared reference for skilled regulatory experts.

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In addition to getting useful to specialists new to US regulatory affairs or as handy reference, several experts preparing for the US Regulatory Affairs Certification (RAC) exam cite Fundamentals as an indispensable RAC study tool. It also has been used as a coaching resource at several healthcare organizations and is a mandatory text for university-level courses.

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Fundamentals of US Regulatory Affairs, Eighth Edition is offered each in print and as an e-book for $ 249.95 with cost-free shipping for RAPS members or $ 309.95, plus shipping, for nonmembers.

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About RAPS

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The Regulatory Affairs Specialists Society (RAPS) is the largest worldwide organization of and for these involved with the regulation of healthcare and associated items, such as health-related devices, pharmaceuticals, biologics and nutritional merchandise. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively assistance the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS provides education and instruction, skilled standards, publications, research, understanding sharing, networking, profession development possibilities and other worthwhile resources, such as Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org

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FDAImports.com and Benjamin L. England and Associates Add Lawyer, Regulatory Specialist, and Administrative Associates

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Glen Burnie, MD (PRWEB) June 12, 2013

FDAImports.com, LLC and Benjamin L. England and Associates, LLC continue to expand in their efforts to provide quick, competent, satisfying legal and regulatory counsel to FDA- and USDA-regulated businesses around the world. Join us as we welcome an attorney, a regulatory specialist, and two administrative associates.

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Ge Song&#13

Ge is an lawyer with Benjamin L. England &amp Associates, LLC practicing Food and Drug Law, with a dual legal education: she holds a Bachelor of Laws from the University of International Organization and Economics in Beijing, China, and both a Master of Law in Intellectual Property &amp Technology and a Juris Medical professional from Washington University in St. Louis. Although pursuing her J.D., Ms. Song interned with the U.S. Securities and Exchange Commission, in its Enforcement Division in Washington, D.C. She studied for a year at Georgetown University, and interned there with Adjunct Professor Honorable Judge Francis M. Allegra of the Court of Federal Claims. She is admitted to the New York Bar. In her free time, Ms. Song enjoys reading literature and watching shows.

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Yun-Sang Cheah &#13

Yun-Sang (Naomi) is a Regulatory Specialist with FDAImports.com, LLC. She earned a B.S. in Life Sciences, with a specialty in Biotechnology, from Zhejiang University, Hangzhou, China, and graduated in Could 2013 with an M.S. in Public Overall health from Johns Hopkins College of Public Health in Baltimore. Ms. Cheah provides enterprise consulting and regulatory help to the firm’s meals and drug clients. She is fluent in Mandarin, Cantonese and Malay. In her free time, she enjoys reading, dancing, playing sports, and cooking.

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Alison Johnson&#13

Alison is an Administrative Associate. She holds a Bachelor of Business Administration from Texas Christian University, with concentrations in Management and Marketing and advertising. Alison handles a multitude of bookkeeping responsibilities for the firm, as well as a wide range of particular projects that are finance and/or human resources-related. In her totally free time, she enjoys downhill skiing, culinary adventures, and traveling.

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Nichole Sheppard&#13

Nichole is an Administrative Associate. She attended Sojourner Douglass College, where she lately graduated with a Bachelor of Arts in Administrative Management. As an Administrative Associate, Ms. Sheppard is accountable for Accounts Receivable and client invoicing. In her cost-free time, she enjoys spending time with her family members and buddies and going to the beach throughout the summer season.

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About FDAImports.com &#13

FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate by way of and meet complicated FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and health-related devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Get in touch with: Anne Lehan, (410) 220-2800 or pr(at)fdaimports.com.&#13

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“Alert Gum” Highlights Uncertain Regulatory Status of Caffeine

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Hampton, Virginia (PRWEB) May 31, 2013

In April 2013, Wrigley launched Alert Power Caffeine Gum with much fanfare. Nonetheless, the U.S. Food and Drug Administration’s (FDA’s) concerns about the added caffeine in foods caused Wrigley to take its Alert Power Caffeine gum, which has the exact same amount of caffeine as half a cup of coffee, off the industry. Wrigley announced that “it had stopped new sales and advertising and marketing of Alert Power Caffeine Gum ‘out of respect’ for the F.D.A.” Registrar Corp, an FDA consultancy firm, assists companies with troubles associated to labeling and ingredients.

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This circumstance highlights the recent focus on the avalanche of caffeinated foods entering the U.S. marketplace. Meals makers have been adding caffeine to a assortment of foods: potato chips, jelly beans, energy drinks, to name a couple of. FDA issued a statement applauding Wrigley for its selection and announcing the agency’s intent to work “with industry, the scientific and healthcare community, and all interested parties to address the concerns posed by added caffeine in foods and beverages.”

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The heart of the situation lies in how FDA regulates substances added to food. “Meals additives” are these substances added to meals that have not been normally recognized as secure (GRAS). Meals additives should be authorized by FDA through the meals additive petition method and are then codified into regulation. GRAS substances are those substances that are usually recognized, amongst certified authorities, as possessing been adequately shown to be secure beneath the circumstances of their intended uses. This can be established by way of a widespread history of consumption for meals use. Alternately, it can be created via scientific procedures, requiring the same quantity and top quality of scientific proof as would be essential to get approval of the substance as a food additive. GRAS substances might be self-affirmed by the manufacturer or affirmed by FDA and written into regulation. A business might also submit a GRAS notice to FDA to inform the agency of their determination that a substance is GRAS. FDA particularly affirmed caffeine as GRAS for “cola-variety beverages” with a tolerance level of .02%. The addition of caffeine to other types of food items is not covered by the regulation. So is caffeine added to gum (or potato chips, or jelly beans) regarded as GRAS? If not, one could argue that the addition of caffeine to these merchandise tends to make it an “unapproved food additive” and for that reason the item is adulterated.

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When announcing its choice, Wrigley stated “we have a greater appreciation for its [FDA’s] concern about the proliferation of caffeine in the nations food provide. There is a need for modifications in the regulatory framework to greater guide the shoppers and the business about the appropriate level and use of caffeinated products.” FDA has stated its intent to take “a fresh appear at the prospective influence that the totality of new and simple sources of caffeine may possibly have on overall health, especially vulnerable populations such as children and youth, and if necessary, will take proper action.” Food makers will require to be ready to affirm the security of caffeine at the levels found in their items.

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Registrar Corp aids food and beverage exporters to comprehend and comply with U.S. FDA regulations. Registrar Corp welcomes meals and beverage companies to attend a seminar on U.S. FDA Food and Beverage Labeling Regulations as part of the Akademie Fresenius Conference at the Atrium Hotel Mainz in Mainz, Germany on June 18-19, 2013.

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Organizations contemplating the development of goods containing food additives (i.e. caffeine) may possibly want to contact a regulatory specialist, such as Registrar Corp. Registrar Corp’s Label &amp Ingredient Assessment service will inform businesses of the regulatory status of their components so that they may decide no matter whether it will be permitted by FDA. For a lot more info about food ingredients, labeling and other FDA regulations, please get in touch with Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

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