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The Twelve Principles of Green Chemistry: Atom Economy
Feb 24 2021
Next up in our twelve principles of green chemistry series, we are talking atom economy! Much like the previous piece focusing on waste prevention, this piece will give an overview of atom economy and how it relates to green chemistry. Keep reading to recap our previous principle and learn about the second principle of green…
The Promise of Antisense Oligonucleotide Drug Products and ‘N-of-1’ Trials for Rare Diseases
Feb 22 2021
In January 2021, FDA issued draft guidance for IND Submissions for Individualized Antisense Oligonucleotide Drug Products Administrative and Procedural Recommendations. The guidance is intended for sponsor-investigators developing individualized antisense oligonucleotide (ASO) drug products for severely debilitating or life-threatening genetic diseases. FDA recognizes typically individuals with these diseases will likely not have FDA-approved treatment options. Additionally,…
Changes to an Approved NDA or ANDA: Frequently Asked Questions
Feb 18 2021
Holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) may want to make post-approval changes to their products, in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 314.70. FDA’s Guidance for Industry: Changes to an Approved NDA or ANDA, provides recommended reporting categories…
The Use of Platform Methods in Impurities Testing of Biologics
Feb 11 2021
Biopharmaceutical drug products are monitored for critical quality attributes during regulatory filings and throughout the development of manufacturing processes. Critical quality attributes (CQA) are defined by FDA as “a property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired drug quality/safety.” Impurities are potential CQA, and impurities that…
Q&A on the FDA’s Veterinary Feed Directive Regulation
Feb 9 2021
Before 1996, there were only two options for animal drugs, over-the-counter (OTC) and prescription. In 1996, Congress enacted the Animal Drug Availability Act (ADAA) to encourage the approval and marketing of new animal drugs and medicated feeds. Part of this act addressed how these products should only be administered under a veterinarian’s order and professional…
The Twelve Principles of Green Chemistry: Waste Prevention
Jan 27 2021
We have previously written pieces of content in and around green chemistry, green reformulation and just generally about green innovation. Today starts a twelve-part series focusing on the twelve principles of green chemistry. These principles help guide chemists who work in/with anything considered ‘green.’ Continue reading on to learn about the first of twelve principles,…
E- Liquid Companies who Didn’t Submit PMTA Applications by Deadline Receive Warnings to Remove Unauthorized E-Liquid Products from Market
Jan 18 2021
On January 15, 2021, FDA issued the first set of warning letters to firms who haven’t submitted premarket tobacco applications (PMTAs) to FDA and have continued to sell or distribute unauthorized electronic nicotine delivery system (ENDS) products after the PMTA filing deadline of September 9, 2020. New tobacco products on the market as of August…
Avomeenians Lend a Helping Hand
Jan 12 2021
Helping out our community is something Avomeenians hold near and dear to our heart. From our Living Our Values Community Stewardship Award to our 2020 Walk for Diabetes Campaign to raise funds for research, education and patient care at the Elizabeth Weiser Caswell Diabetes Institute, Avomeen is no stranger to being involved in our community.…
Living Our Values – Scientific Excellence Spotlight: Kamil Toga
Dec 22 2020
Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles, and the Scientific Excellence award recognizes a scientist who goes above and beyond in all of their scientific work. We’re learning more about Kamil Toga, the recipient of this award, in a Q&A…
Living Our Values – Client Centricity Spotlight: Emma Leishman
Dec 17 2020
Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles, and the Client Centricity award recognizes a chemist who goes above and beyond for each client they serve. Today, we’re getting to know Emma Leishman the recipient of this award, with a little…
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