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 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 clinical partners, 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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Pharma Formulation Services Blog Series, Part 1: Solving a Problem

Jul 5 2019

The Role of Pharmaceutical Formulation Development Unlike other drug development activities, which are checkbox activities to meet FDA requirements, a good formulation solves a problem: “I’ve got this new molecule with fantastic in vitro activity, but how do I dose it? Will it be stable?  Can I measure this?  Is this suitable for the given…

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E-Liquids Extractables and Leachables Testing for the PMTA

Jul 2 2019

Extractables & Leachables Studies are Required in the New PMTA Guidance Extractable and leachable testing (E&L) is now a requirement of the PMTA per the June 2019 guidance. E&L studies are not new to the FDA, as they are mainstay requirement in pharmaceutical products and submissions. E&L studies are used to test product packaging to…

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Prop 65 60-Day Notice: What You Need to Know

Jun 27 2019

California Prop 65 Statute Companies with 10 or more employees whose products are sold or distributed within the state of California need to be aware of and comply with Prop 65 Regulations passed via the Safe Drinking Water and Toxic Enforcement Act of 1986. Businesses must confirm whether any of the more than 950 Proposition…

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What to do When a Process or Product Fails

Jun 25 2019

What do you do When a Process or Product Fails? All processes and products have the potential to fail. What do you do when a process or product fails? When engineering controls are insufficient to prevent failure, evaluating the process, raw materials, and the conditions of use is important when investigating the root cause. How…

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Overview of Premarket Tobacco Application (PMTA) FDA Guidance for ENDS

Jun 21 2019

When was the PMTA Guidance Released? In May 2016, the FDA initiated planned requirements for e-liquid and tobacco chemicals testing. Premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) are required to be submitted for every flavor at every nicotine strength, with supporting pre-clinical and clinical safety data. In June of 2019, the…

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Common Pitfalls in Extractables & Leachables Testing

Jun 20 2019

Extractable and Leachable Regulations & Requirements Extractables and leachable studies are required for pharmaceutical product submissions in order to ensure that plastic and rubber chemicals do not transfer into drug products at levels that cause public health concerns.  These studies are customized and although there exist guidances from both the United States Pharmacopeia (USP) as…

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Avomeen Hires New Head of Elemental Analysis

Jun 17 2019

John Ferencz brings 12 years of chemistry experience to Avomeen to help grow its elemental analysis testing capabilities Avomeen Analytical Services recently announced John Ferencz as the new leader of its Elemental Analysis division. In this role, he will be responsible for overseeing a growing lab unit that specializes in analysis of heavy metals and…

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