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Breaking Down the FDA’s Biosimilars Action Plan: Biosimilars and You

Feb 21 2020

Back in July 2018, the FDA released their Biosimilars Action Plan. This plan aimed to help create competition in the marketplace, increase innovation in biosimilar development and further build the positive reputation of biosimilars with patients and doctors alike. The FDA recognized a need for a more timely approval process in the biosimilar market while…


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Green Reformulation & Your Company: How You Can Go Green

Feb 14 2020

According to the EPA, greener products can help protect human health and the environment. Products also play an impact in air pollution, water pollution, climate change, waste disposal and damage to ecosystems. These staggering impacts can occur at many places throughout the product life cycle. Because of this, many consumers are more conscious about the…


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FDA Prioritizing Enforcement of ENDS Products without Premarket Authorization

Feb 7 2020

FDA is Prioritizing the Enforcement of Flavored, Cartridge-Based E-Liquid and ENDS Products without Premarket Authorization Beginning February 6, 2020, FDA is prioritizing the enforcement of ENDS products which are currently marketed without FDA authorization, focusing on the following products which have gained popularity with minors: Any flavored, cartridge-based e-cigarette, e-liquid, and ENDS product (other than…


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Avomeen’s Annual STEM Scholarship Program

Jan 21 2020

We endeavor to live by our guiding principles, including “our community deserves our involvement”. Throughout year, we undertake a number of initiatives to support the community in which we live and work, including environmental stewardship, fund-raising, and charitable giving. Supporting STEM Education We’re passionate about all things chemistry, and Avomeen is committed to helping others…


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The Importance of Method Verification

Jan 17 2020

Method verification is the process of confirming that an existing method is suitable for a given product or matrix. If the standard method changes, the confirmation or verification should be repeated. Method verification is vital when: Transferring an already validated method The matrix being tested is not one that was used or cited in the…


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Meet PMTA Submission Deadlines and Comply with 2-Year Stability Requirements

Jan 15 2020

For vape, e-liquid, and ENDS companies looking to comply with the quickly approaching May 2020 Premarket Tobacco Application (PMTA) filing deadline, stability data must be included in their PMTA submission. If you’re familiar with the PMTA guidance, you may be wondering how 2 years of stability data can be generated in a few months’ time…


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FDA Bans Flavored E-Cigarette Cartridge Products

Jan 2 2020

In 2019, some significant dates and timelines for the Premarket Tobacco Application (PMTA) were established. In June of 2019, the FDA issued its final guidance on the PMTA stating that vaping manufactures need to submit their PMTA by August 2021. This time frame was very short lived, as in July of 2019, the Maryland District…


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Your CRO/CDMO Can and Should Do More than Deliver Data

Dec 31 2019

Have you asked lately what more your CRO (contract research organization) or CDMO (contract development and manufacturing organization) can do for you? It’s a fair question, and one you should be asking. Your CRO/CDMO should be more than just another service provider or vendor – they should be your partner. Utilize Your CRO’s Network and…


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FDA Investigates NDMA Impurity in Metformin Diabetes Medicines

Dec 18 2019

FDA has recently been investigating the presence of nitrosamines in drug products. During the course of the investigation, ranitidine (also known as Zantac) was found to contain small amounts of N-Nitrosodimethylamine (NDMA). In order to ensure drug products continue to meet stringent quality standards, FDA has been conducting an ongoing investigation into the presence of…


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FDA Requires Release Testing of Ranitidine and Nizatidine Due to NDMA Impurity

Dec 10 2019

On December 4, 2019, FDA announced that ongoing testing of OTC and prescription ranitidine (commonly known as Zantac) and nizatidine products is required due to the detection of an N-nitrosodimethylamine  (NDMA) impurity. NDMA Impurity Testing in Ranitidine (Zantac) and Nizatidine Several weeks ago, FDA launched an investigation to: Understand the source of the NDMA impurity…


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