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FDA Grants First-Ever Modified Risk Orders for Smokeless Tobacco Products

Nov 14 2019

FDA recently granted the first-ever modified risk orders to eight smokeless tobacco products. In a recent press release, FDA announced the authorizations are for Swedish Match USA, Inc. snus smokeless tobacco products, which are marketed and sold under the “General” brand name. The Products were Previously Authorized Under PMTA The 8 snus smokeless tobacco products…


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Best-In-Class Polymer Additive Library for Identification of Extractables

Nov 12 2019

In the biopharmaceutical industry, it’s important to identify extractables and leachables for patient safety and submissions to regulatory authorities.  Impurities can originate from process components, manufacturing equipment, packaging materials, and container closure systems used in the development of a drug product. Extractable and leachables (E&L) studies detect and identify the organic and inorganic compounds that…


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Development of a Library of Plastic Additives for Identification of Extractables Poster Presentation

Nov 5 2019

Avomeen’s extractables and leachables (E&L) team are attending AAPS PharmSci360 November 3-6, 2019 in San Antonio, Texas. If you’re able to attend, be sure to check out our poster, Development of a Library of Plastics Additives for Identification of Extractables. If you can’t make it to the show, we’ve got you covered. Additional Resources The FDA…


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Development and Validation of In Vitro Release Test (IVRT) Method for Ophthalmic Suspensions Poster Presentation

Nov 4 2019

Avomeen’s pharmaceutical formulation team are attending AAPS PharmSci360 November 3-6, 2019 in San Antonio, Texas. If you’re able to attend, be sure to check out our poster, Development and Validation of In Vitro Release Test (IVRT) Method for Ophthalmic Suspensions – A Walkthrough Exercising Regulatory Guidance. If you can’t make it to the show, we’ve got…


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Supporting Animal Rescue Organizations is Totally Pawsome

Nov 1 2019

We believe our community deserves our involvement, and in 2019, our team has come together to support local animal rescue organizations. 2019 Doggie Dash Avomeen employees came together along with their 4-legged best friends to support Michigan Humane Society on October 5 at the 2019 Michigan Humane Society Doggie Dash. The Avomeen team, “Totally Pawsome”,…


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The Key to Successful New Product Development & Innovation

Oct 22 2019

Innovative thinking and ideas often are found though expertise, experimentation, and fresh perspective. At Avomeen, we foster an environment that allows our team to be innovative. Our unique team build allows us to delve into a wide range of formulation needs, ranging from the complex to everyday essentials. Our ability to design proven models for…


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Pharma Formulation Services Blog Series, Part 4:  Wraparound Activities – Measuring Success

Oct 8 2019

Behind every good formulator is… well, are… a number of good analytical chemists.  They play a critical role in everything from measuring solubility, potency, and dissolution to monitoring purity and stability.  Every step in the formulation development process requires some sort of analysis.  Enter, the analytical chemists.  Below, we discuss some of the techniques and…


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New FDA Statement on Impurities in Drug Products

Oct 1 2019

FDA published a statement on September 13, 2019 concerning a nitrosamine impurity in some ranitidine (brand name Zantac) medicines.  The impurity is called N-nitrosodimethylamine (NDMA). The FDA has been investigating NDMA in certain heart medications, Angiotensin II Receptor Blockers (ARB’s), since 2018. In June 2018, US manufacturer Prinston Laboratories Inc. contacted FDA about its valsartan-containing…


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FDA Issues Proposed Rule for ENDS PMTA Pathway

Sep 27 2019

On September 20, 2019, FDA issued a proposed rule which will clearly define requirements for the regulatory pathway for Premarket Tobacco Applications (PMTA). The rule will: Detail content requirements Establish the format for PMTA submissions Specify electronic submission requirements Detail requirements for filing amendments, withdrawal of applications, changes in ownership, and post-market reporting Set requirements…


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Proposed E-Liquid Bans and the PMTA

Sep 24 2019

The Electronic Nicotine Delivery System (ENDS) industry continues to face a quickly-evolving regulatory landscape, which now includes several state-led bans on flavored e-liquid and vape products. Additionally, the industry faces the possibility of a federal ban which is supported by the Trump administration. How Proposed Vape Bans Impact PMTA Strategy While common regulatory strategies for…


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