Showing items tagged as FDA

  • The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

    16 May, 2017 by Maile Gradison Hermida and Brian D. Eyink, Hogan Lovells US LLP

    With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare

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  • Keeping Up With the Top Pharma Industry Trends of 2017

    18 May, 2017 James Jardine, Staff Writer, MasterControl

    A close look at the key trends that will have the biggest impact on the pharmaceutical industry this year.

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  • Why It’s Time to Revisit FDA’s Quality by Design

    1 June, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.

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  • Understanding FDA’s UDI Guidance: The Key to Compliance

    13 June, 2017 by Beth Pedersen, Staff Writer, MasterControl

    The latter half of 2016 saw the second highest number of U.S. medical device recalls since 2000 with 650 medical devices and over 180 million units pulled from the market, according to Stericycle ExpertSOLUTIONS’

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  • The Quality Metrics Journey

    15 June, 2017 by Susan Schniepp, Fellow, Regulatory Compliance Associates Inc

    One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.

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  • Required Records of Selected Regulations Under the Food Safety Modernization Act

    20 June, 2017 by Erika Miller, Food Safety Specialist, D.L. Newslow and Associates

    The Food Safety Modernization Act, or FSMA (2011), has dominated the conversation in food safety circles for quite some time now. Compliance dates are arriving, and companies are realizing there is a lot to be done to become compliant. Companies that traditionally had little to no contact with the FDA (if everything was going right) are now seeing activity, whether anticipated or not.

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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 by Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

     At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines

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  • FDA Favors Collaborative Approach to Medical Device Cybersecurity

    13 July, 2017 by David Jensen, Staff Writer, MasterControl

    Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the subject at MedTech Intelligence’s conference on Medical Device Cybersecurity.

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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 by UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • UDI as Med Device Product Tracking Software (Why That’s a Good Thing)

    1 August, 2017 By Cindy Fazzi, Staff Writer, MasterControl

    When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?

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  • Is the 510(k) Process as Worthless as the Federal Courts Seem to Believe?

    3 August, 2017 by Jeffrey K. Shapiro, Director, Hyman, Phelps, McNamara, P.C.

    Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says 

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  • Nuts and Bolts of 510(K) Submissions

    17 August, 2017 by Rob Packard President, Medical Device Academy, Inc.

    A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

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  • Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

    24 August, 2017 by Stephanie Gaulding, CQA, CPGP, DPS Engineering

    I had the pleasure spending two days networking and discussing quality metrics and quality culture with industry and FDA leadership at PDA's 2017 Quality Metrics and Quality Culture Conference last February. This year's conference included some of the most candid and honest dialog on these topics that I've seen between industry and FDA to data. I thought I would share some of the messages and my takeaways from the two-day event.

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  • 10 Things I Wish I’d Known Before Writing my FDA Response Letter

    25 August, 2016 Lisa Weeks

    If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

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  • UDI: When the Rule is Not Enough

    30 August, 2016 MasterControl

    With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

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  • How Well Do You Know Your FDA History?

    6 October, 2016 Lisa Weeks

    Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start

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