ADPEN Laboratories

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ADPEN Laboratories featured in Tecan Journal

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ADPEN Laboratories was featured in the Tecan Journal 3/2013 under the Mass Spectroscopy section. The article entitled “Meeting the demands of Mass Spectroscopy sample preparation” discusses ADPEN’s use of the Tecan Freedom Evo 100 robotic liquid handler. The Evo is used as part of ADPEN’s high throughput strategy for sample preparation. ADPEN ran many method trials to test the system’s robustness and validate the platform, successfully demonstrating that automation on the Freedom EVO was as good as, or better than, manual procedures.

Click on the image below to read the article or go Tecan Journal online to read the entire edition.

FDA Issues Final Rule on Clinical Investigator Disqualification

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FDA has amended the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted. This rule is effective May 30, 2012.

To read the final rule visit this web link.

FDA Extends Enforcement Discretion Period for Phytosterol Claims

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FDA says it will extend the enforcement discretion period for phytosterol-and-heart-disease claims until publication of a final rule.

In September 2000, FDA issued an interim final rule allowing a claim of reduced risk of coronary heart disease (CHD) for eligible products fortified with phytosterols. Since then, parties have petitioned for more eligible products, eligible phytosterols, and eligible phytosterol forms, and the FDA has even increased the required usage levels for phytosterols (0.5 g per RACC) in products bearing the claim. For years, all of this has been subject to an enforcement discretion period during which time manufactures have been allowed to go off of initial phytosterol requirements without penalty.

Most recently, the enforcement discretion period was set to expire on February 21, 2012. Products marketed after this date would have to meet all new changes to bear the heart health claim.
[Read more…]

NPA Revamps GMP Seminars to Address Changing Regulatory Environment

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The Natural Products Association (NPA) has updated the popular Good Manufacturing Practices (GMP) training program, “What You Need to Know: How the FDA GMP Rule for Dietary Supplements Applies to You.” In light of the Food and Drug Administration’s emphasis on GMP inspections, this course is vital for anyone whose job requires an understanding of the GMP rule for dietary supplements. This includes senior management, regulatory affairs staff and QA/QC, production and laboratory personnel. The first opportunity to attend this seminar will be at Expo West on March 8-9 in Anaheim, Calif. Learn more and register at www.NPAinfo.org/GMP.

The newly-revised program now includes:
•Issues identified in recent FDA inspections and warning letters.
•Examples and case studies illustrating real-life GMP issues and scenarios.
•An overview of industry business models and their respective GMP responsibilities.
The updated format brings more emphasis on the application of what is required for GMP compliance. Companies will be able to use this information to meet their GMP requirements.
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ABC Publishes Article Documenting Supplement Regulations

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Dietary supplements are subject to a wide array of federal government regulations in the U.S., according to a new report published by the non-profit American Botanical Council (ABC), Austin, TX. The article notes numerous authorities to regulate dietary supplements that are granted to FDA and FTC, as well as other government agencies.

The article, titled “The Regulated Dietary Supplement Industry: Myths of an Unregulated Industry Dispelled,” has been published online and will appear in the winter issue of ABC’s quarterly, peer-reviewed journal HerbalGram. It is the second from ABC on this subject; in 2000, ABC published a seminal article titled “Regulation in the Herb Market: The Myth of the ‘Unregulated Industry’” in HerbalGram. It was written by the co-author of the present article, R. William Soller, PhD, an expert on health policy and the use of nonprescription medications for self-care who has a long history in the regulation of both dietary supplements and nonprescription medications.

Now, just more than a decade later, Dr. Soller, Holly J. Bayne, Esq.—a Washington, D.C.-based attorney specializing in food and drug law with a focus on dietary supplements and botanicals—and Christopher Shaheen, a researcher at the University of California – San Francisco (UCSF), have developed a greatly expanded follow-up article to clarify the breadth and depth of regulation of dietary supplements.
[Read more…]

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“Special thanks to the ADPEN team for striving to get the analysis we need in a timely manner.” -R.W.

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ADPEN Laboratories, Inc.
11757 Central Parkway
Jacksonville, FL 32224 USA

Phone: 1.904.645.9169
Fax: (904) 641-8423
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