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Showing items tagged as FDA

  • The Right EQMS for the Homeopathy Crackdown

    18 January, 2018 by Sarah Beale, Staff Writer

    For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. Traditionally the FDA hasn't been involved with homeopathy, but this new guidance means that companies will have to become compliant with these six risk-based categories.

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  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    26 December, 2017 by James Jardine, MasterControl Communications

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

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  • Three Common Reasons Biologics Companies Receive FDA Form 483 Notices

    21 December, 2017 by Marci Crane

    Biologics companies that wish to sell product in the United States should be ready at all times for a Food & Drug Administration (FDA) inspection. FDA inspectors have the authority to issue a Form 483 notice, which is a documented form that communicates when a company’s practices are not in compliance with regulatory standards.

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  • How Santa’s Kitchen Prepares for an FDA Inspection

    19 December, 2017 by Marci Crane

    Before Santa can fill the stockings of good children from across the world, he and his elves must be inspected and/or audited by certified auditing bodies and similar organizations from around the world. Why? Because Santa must prove that the sweet treats he manufactures measure up to high quality standards for all children everywhere.

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  • FDA Draft Guidance on Electronic Records and Signatures: The Next Chapter

    7 December, 2017 by Betsy Fallen, BAFallen Consulting LLC

    Just about everyone in the drug development industry has cited 21 CFR Part 11 at one time or another. Fondly referred to as “Part 11,” the August 1997 regulation was last referenced by the FDA in 2003 with the release of a Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application.1 Since then, the centralized research team has significantly changed from only a few stakeholders into a system of many globally distributed contributors. The industry’s documentation has transitioned from paper files to dynamic, integrated systems supporting digital records spanning the bedside to the research clinic. The delivery of healthcare has evolved from the confines of brick and mortar to cloud-based platforms that could only be dreamed of a few years ago.

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  • Infographic: 10 Common Pains in Dossier Management for Med Device Firms

    30 November, 2017 by Cindy Fazzi, Staff Writer

    People say a picture is worth a thousand words. The 10 common pains in dossier management described in this infographic is worth ten thousand words given how much they affect the daily work of regulatory professionals and submission managers.

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  • FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device

    29 November, 2017 by Rachael E. Hunt & Allyson B. Mullen

    On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a significant number of comments, the final guidance is largely unchanged from the 2016 draft. Industry should also be comforted to know that the final guidance is also, at its core, very similar to the 1997 guidance – a welcome relief as compared to the 2011 draft guidance.

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  • Gottlieb Says FDA Wants to Widen Access to Better Compounded Drugs

    13 October, 2017 by Karla L. Palmer

    We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance on changes in outsourcing facility compounding in the coming months. FDA’s announcement about draft outsourcing guidance is somewhat of a headscratcher, especially considering that a number of anticipated compounding guidance documents and regulations were recently moved to CDER’s regulatory agenda inactive list (here; search "drug").

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  • Coping with Scoping a CSV/Part 11 Audit

    21 September, 2017 by Laurie Meehan, Social Media Manager; Polaris Compliance Consultants

    You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

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  • Rise of Digital Health Prompts FDA to Re-examine How It Regulates SAMD

    7 September, 2017 Jeffrey K. Shapiro; Hyman, Phelps, McNamara, P.C.

    When you think about it, FDA's general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/MDR/Part 806 and QSR procedures for the postmarket phase.)

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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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  • Thoughts from 2017 PDA Quality Metrics and Quality Culture Conference

    24 August, 2017 MasterControl

    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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  • Nuts and Bolts of 510(K) Submissions

    17 August, 2017 MasterControl

    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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  • Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?

    3 August, 2017 MasterControl

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

    1 August, 2017 Cindy Fazzi, Staff Writer

    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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  • FDA Favors Collaborative Approach to Medical Device Cybersecurity

    13 July, 2017 David Jensen

    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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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 MasterControl

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

    20 June, 2017 MasterControl

    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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  • The Quality Metrics Journey

    15 June, 2017 MasterControl

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

    13 June, 2017 Beth Pedersen

    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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