Showing items tagged as FDA

  • FDA Issues New Draft Documents Related to Compounding of Human Drugs

    23 February, 2015 MasterControl

    The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    19 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

    18 February, 2015 Suzanne M. O'Shea, Counsel, Faegre Baker Daniels LLP

    Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1] These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2] Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.

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  • FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

    10 February, 2015 Ken Christie COO, VTS Consultants, Inc.

    If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

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  • CAPA Should Not Be a Dreaded Four-Letter Word

    5 February, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

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  • Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

    23 December, 2014 Cheryl Wagoner, Principal Consultant/Owner, Wagoner Consulting LLC

    As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices,

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  • A Bipartisan Success at Getting Drugs to the Pharmacy Faster (and Cheaper)

    2 December, 2014 Suzanne Junod, U.S. Food and Drug Administration

    Most medications used to be expensive – much more expensive than they are today. As recently as the early 1980s, most important drugs on the market were brand names under patent protection. Generics were uncommon; the cost of developing and marketing them in competition with the big brands was too high. Without change, the relative ease with which most of us get and use prescription drugs today might have been quite different.

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  • FDA vs. EU Inspections: Similarities & Differences

    14 October, 2014 Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative

    The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

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  • Change Control and Its Role in Continuous Quality Improvement

    17 April, 2014 by Lisa Weeks, Marketing Communications, MasterControl Inc.

    The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and more importantly, being able to control it, is critical to maintaining compliance. Of course, it’s not just regulatory agencies that are demanding higher-quality products; today’s more sophisticated consumers expect the medicines, automobiles, and devices they purchase to be safe and effective, too. They also expect them to cost less and be developed more quickly and efficiently. Better, safer, faster, cheaper…it’s a tall order for any regulated company. Organizations that respond quickly to increased regulation and consumer sophistication will become inherent market leaders. How does your company respond to change?

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  • Demystifying FDA/CDRH Appeals Process

    3 April, 2014 by David Lim, President and Principal of Regulatory Doctor and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.

    We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.

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  • Changing Supplier Controls Requirements

    26 March, 2014 by John E. Lincoln, J.E. Lincoln and Associates

    Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.

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  • What Does the New FDA Guidance on Electronic Submissions Mean?

    25 February, 2014 by Cindy Fazzi, Marketing Communications, MasterControl Inc.

    Two years after the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, the FDA has taken a step forward in requiring electronic submissions under FDASIA. Do you know how this new requirement is going to affect your submissions?

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  • Beyond Writing It Down

    19 February, 2014 by David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

    “If it isn’t written down it didn’t happen” is drummed into everyone working within the pharmaceutical industry.

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  • Digging up Root Cause

    23 January, 2014 Robyn Barnes, Public Relations, MasterControl Inc.

    Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group. He was wondering where the term “root cause” came from.

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  • Three Common Issues Involving Clinical Trials

    24 October, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    In clinical research, there are two major regulatory concerns: patient safety and data integrity. While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.

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  • Ten Points for Successful Use of TPLC Reports

    8 October, 2013 Maria Fagan, President, Regulatory & Quality Solutions LLC

    A Total Product Life Cycle (TPLC) Program ensures that quality is proactively designed into medical devices from concept to market, and during post market surveillance until device obsolescence.

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  • How to Prepare your Design History File (DHF) for an FDA Inspection

    10 August, 2013 Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com

    FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article:

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  • Drug Accountability in Clinical Trials

    3 May, 2012 Dr. Robbie Wong, Pharm.D., Clinical Development Consultant and Affiliate Assistant Professor, Dept. of BioEngineering, University of Washington

    It's not exciting, it's not cutting edge. It may be the last thing you think about when preparing for an FDA audit. You might scan the records and figure if all the lines are filled in, it must be okay. Or, the auditor might not look at it, so I will trust that the pharmacist did it correctly. After all, aren't pharmacists one of the most trusted professions? Consider this: if drug accountability is in question, then the whole study could be in jeopardy. Proving that the drug was administered to the patient that resulted in the effects seen from study drug is a key factor in determining the merit of a product candidate. The FDA has listed drug accountability as number three in a list of top five pitfalls.

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