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Understanding Chemistry, Manufacturing and Controls (CMC)

Aug 4 2020

Chemistry, Manufacturing and Controls (CMC) is an integral part of any pharmaceutical product application to FDA. CMC is critical to attaining a successful registration filing. CMC is applicable to the entire product lifecycle – it starts during the drug candidate selection phase, and continues through post-approval and beyond. Chemistry, Manufacturing and Controls: The Basics of…

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Reviewing FDA’s New Gene Therapy Guidances on LTFU

Jul 31 2020

In the past few years, gene therapy has turned from concept into reality. The first gene therapy clinical trial was conducted in 1990. However, the FDA only approved the first gene therapy product in August 2017. In January, the FDA released a new guidance for gene therapy products. These guidances primarily revolve around the long…

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Tainted Goods: The Purpose of Textile Testing & Chemical Identification

Jul 28 2020

As a consumer, what your clothing items are made of does not often cross your mind. We may understand that it’s made of cotton, silk, linen, wool, etc., but we may not understand what is involved in that process. Sometimes there can be toxic chemicals within the fibers of the fabrics or left behind on…

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Mycotoxins: Applications & Testing Methodology

Jul 27 2020

Mycotoxins are naturally occurring toxins that are produced by certain molds, and can cause a variety of adverse health effects in humans and other animals. Mycotoxins can accumulate on food commodities as well as animal feed and natural raw materials that are used in a variety of applications, including dietary supplements. They have also been…

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ANDA Regulatory Pathway: Stability Testing FAQs

Jul 23 2020

Do you have questions about FDA’s guidance for industry regarding Abbreviated New Drug Application (ANDA) stability requirements? We caught up with Avomeen’s CMC expert, Neelam Varshney, to answer the most frequently asked questions about ANDAs: Stability Testing of Drug Substances and Products. Does FDA’s ANDA stability testing guidance apply to post approval changes? No, it…

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Join Avomeen’s PMTA Consortium Program

Jul 15 2020

As the September 9, 2020 PMTA deadline draws near, many ENDS companies are either already working or starting to work through the testing and application process. We’ve been in communication with a large number of companies over the last few weeks, and it’s becoming clearer the stresses of navigating the overall process combined with the…

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ANDA Regulatory Pathway: Q1/Q2 (Q3) Deformulation & Equivalence

Jul 6 2020

Deformulation, also known as reverse engineering, is a key part of generic pharmaceutical drug formulation and the abbreviated new drug application (ANDA) process. According to FDA’s Generic Drug Facts, “a generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality,…

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Living Our Values – Scientific Excellence Spotlight: Khanh Ngo Courtney, Ph.D.

Jun 25 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 consistently develops and delivers scientifically advanced solutions. We’re getting to know Khanh Ngo Courtney, the recipient of this award, with a little Q&A: For…

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PMTA Trends in Rejections

Jun 24 2020

Premarket Tobacco Applications (PMTAs) Since Program Inception Since the Premarket Tobacco Application (PMTA) program was established in October 2014, approximately 417 Premarket Tobacco Applications have been submitted. A majority of these were in the summer of 2016. However, to date, only 15 PMTAs have been approved. According to the FDA, 85.2% of submitted PMTAs are…

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Living Our Values – Teamwork & Collaboration Spotlight: Haley Hamel

Jun 23 2020

Avomeen’s Living Our Values Awards program provides us with an opportunity to celebrate those who exemplify our core values and guiding principles. The Teamwork & Collaboration award recognizes a member of our support staff for internal customer service, and the recipient is selected by an all-staff vote. Haley received a record number of votes –…

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