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FDA Issues Warning Letters for E-Liquid Products without Marketing Authorization

Aug 13 2019

On August 8, 2019, FDA issued warning letters for 44 flavored e-liquid and hookah tobacco products, notifying 4 companies that the cited products can’t be legally sold in the U.S. because they don’t have the required marketing authorization. In a recent press release about the enforcement of Electronic Nicotine Delivery System (ENDS) and hookah tobacco…


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Avomeen Hires New Biological Chemistry Project Director

Aug 8 2019

Khanh Ngo Courtney will help expand Avomeen’s large-molecule and protein therapeutics business Avomeen Analytical Services recently announced Khanh Ngo Courtney as its Biological Chemistry Project Director. Through this newly created position, Courtney will help grow Avomeen’s large-molecule and protein therapeutics business segment by partnering with biopharmaceutical clients who are navigating the large-molecule product development life…


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The Growing Need for Extractables & Leachables (E&L) Testing of Biopharmaceutical Manufacturing Equipment

Aug 7 2019

As part of the drug approval process for the U.S. Food and Drug Administration (FDA), all drugs in development must undergo extractables & leachables (E&L) testing. In the past, the FDA emphasized oversight of E&L testing for drugs that came with both a high-risk route of administration and high risk of packaging and dosage form,…


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2019 FDA PMTA Guidance FAQs

Aug 6 2019

9 Common Questions About the FDA’s new PMTA Requirements With the new FDA PMTA guidance that was released in June 2019, we have received a myriad of questions regarding the guidance, regulatory pathways, and the testing required for a successful PMTA submission. So if you’re wondering about the FDA’s new PMTA requirements, here are the…


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USP 232/233 Elemental Impurities FAQs: Part 2

Jul 30 2019

New and existing NDAs and ANDAs for drug products are required to meet USP <232> and <233> for elemental impurities As of January 1, 2018, generic and branded drug products are required to meet FDA industry guidance regarding elemental impurities. The limits and procedures for the screening and quantification of potentially toxic metal impurities are…


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The Use of Bridging Studies in the PMTA

Jul 23 2019

In the initial PMTA guidance from the FDA published in August of 2016, no mention of bridging studies appeared in that version of the guidance. However, in the new the June 2019 final guidance for PMTA submissions, the FDA specifically refers to bridging studies. FDA widely mentions and accepts bridging studies for a wide range…


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No In-House Lab? No Problem – Consider an FTE

Jul 19 2019

Can’t afford an in-house lab? Don’t want to deal with instrument upkeep and finding and retaining scientific talent? We understand that building and maintaining an in-house lab isn’t for everyone, but for those who need the benefits of an in-house lab without the headache, an FTE (Full Time Equivalent) partnership can be ideal. Choose the…


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ENDS Industry Faces Tighter PMTA Submission Deadlines with May 2020 Fast Approaching

Jul 16 2019

FDA June 2019 PMTA Guidance Deadline for Submission In June of 2019, the FDA issued its final guidance on the Premarket Tobacco Application (PMTA) which detailed that e-cigarette, e-liquid, and vaping manufacturers need to submit their PMTA by August 2021. E-liquid manufacturers, along with their partners in the testing space, including analytical laboratories, toxicology and…


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The Role of the Pharma Quality Unit

Jul 11 2019

Pharma Quality Unit Top 10 Responsibilities Did you know the Quality Unit is the only job description that appears in the Code of Federal Regulations? We’ve outlined the FDA regulations and guidance documents that define the job of the Quality Unit below. The pharma Quality Unit is responsible: 1) To Establish the Quality System The…


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Choosing the Right Partner to Develop a Product

Jul 9 2019

You can’t do everything all by yourself, especially when it comes to formulating a new product. You’ll need to weigh your options and choose the right partner – one that you can trust and rely on to help you develop a product that meets your specifications. Oftentimes, a contract lab is the right choice –…


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