• History of Food, Drug, and Cosmetic Act - Did You Know?

    MasterControl

    by: Kevin Bogert, President of GxP Partners, LLC

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  • Health Canada and FDA Agree to Perform Joint Third-Party Inspections

    4 January, 2010 MasterControl

    Both the FDA and Health Canada (HC) found the proposal of joint third-party inspections to be beneficial. The decision was made after the pilot Multipurpose Audit Program was conducted by the agencies.

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  • GMP Training Exams - Did You Know?

    14 April, 2017 MasterControl

    In the FDA environment, adequate and continuous personnel training is essential in manufacturing safe, reliable, and high-quality products. Companies are required to implement and document GMP training to make sure that their personnel know how to perform their duties within company and industry guidelines. What better way to prove employee competency than through exams? When the FDA investigator comes, your employees should be able to demonstrate their skill level in their daily work, but exam

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  • A GHTF Proposed Guideline - Did You Know?

    MasterControl

    Supplier audits have long been of the utmost importance in the medical device environment and the inspection of products/services provided by suppliers is a practice well worth the time of conscientious manufacturers. However, for those manufacturers that disregard background checks on suppliers there may be a new "failure to comply" risk knocking at their door.

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  • Miconceptions Regarding Generic Drugs - Did You Know?

    MasterControl

    The FDA and the U.S Department of Health & Human Services recently updated and published a fact and myth sheet1 regarding generic drugs. The topic can certainly be a confusing one and this publication helps to "clear the air" when it comes to common misconceptions regarding generic (as opposed to brand name) drugs.

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  • FDA Draft Proposal Gets Strict With Clinical Investigators - Did You Know?

    MasterControl

    The proposal suggests a rule that would disqualify a life science clinical investigator (e.g, a clinical investigator working in the field of biologics) from working on clinical investigations associated with other life science fields such as pharmaceuticals or medical devices. The rule is designed to protect the subjects of clinical research across the various fields regulated by the FDA. The rule would also allow the FDA to harmonize investigator disqualification regulations across the board.

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  • FREE training from FDA CDRH Learn

    10 July, 2011 MasterControl

    For the medical device industry, it's not always easy to understand and correctly implement FDA regulations. CDRH (Center for Devices and Radiological Health) is providing a free online educational tool with training modules that describe "many aspects of medical device and radiological health regulation [that cover] both premarket and postmarket issues."1

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  • Increased Disclosure of Food, Drug and Med Device - Did You Know?

    14 April, 2017 MasterControl

    Did you know that democratic legislators are vying for the increased disclosure of food, drug and medical device information?

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  • Did you know that a newly issued final rule will affect Pharmaceutical and Biologics clinical trials?

    6 October, 2010 MasterControl

    For Pharmaceutical and Biologics companies that organize or participate in clinical trials, final rules issued by the FDA can have a significant impact on policies and procedures related to the implementation of a clinical trial. A recently issued final rule addresses how and when safety information must be reported.

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  • FDA Will Publish Adverse Events Online - Did You Know?

    MasterControl

    For many organizations the Internet has provided an avenue for transparency. The FDA for example, according to FDANews and Drug Industry Daily, is planning to post adverse event evaluations online. The adverse event information will be updated on a quarterly basis and will include summary analyses. Related literature and sources will also be published.

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  • FDA Introduces New Strategy to Ensure Safety of Imported Products

    14 July, 2011 MasterControl

    If your company or organization is subject to FDA regulations, it's important to know that this month marks the introduction of some new and important changes at the FDA.

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  • FDA Changing Medical Device Review - Did You Know?

    MasterControl

    Said changes will include how device data is discussed and the way in which reviewing panels cast their votes for medical devices. Even the subject matter that is voted upon will change. Instead of voting on "approvability," panel members will vote on the safety levels and risks involved with a particular medical device.

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  • Margaret Hamburg Outlines Her Plan - Did You Know?

    MasterControl

    According to the article, Commissioner Hamburg stated the following in a recent meeting:

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  • FDA is Developing a Standardized Format for REMS

    4 January, 2010 MasterControl

    Drug companies know how difficult it can be to develop a solid risk evaluation and mitigation strategy (REMS). In fact, the process can be so difficult that even those assigned to develop the strategy spend much of their time confused about what it is that the FDA wants/requires in a REMS.

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  • FDA Produces List of Common Deviations Found During Lab Inspections

    15 February, 2010 MasterControl

    During 2010, the FDA performed a large number of regulatory inspections and has compiled a list of the most common deviations found. According to www.labcompliance.com, 19 percent of the devations found on the list were "related to unvalidated lab test methods," and that "laboratory controls [issues] ranked as number 1." Additional data points of interest also include quality system and production process control systems which rank at 9 percent and 6 percent respectively. Also according to labco

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  • New Initiative Program for Medical Device Innovation

    15 February, 2010 MasterControl

    On February 8th of this year the FDA announced Innovation Pathway, a new program dedicated to the priority review of new medical devices. The first submission selected for the program is an upper-extremity prosthetic that is controlled by the brain. This device is a pilot and will help determine the efficacy of the program. The FDA will also ask for additional public comment regarding the program before it is implemented on a widespread basis.

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  • Did You Know?

    11 July, 2012 MasterControl

    Did you know that the FDA has proposed a unique device identification system for medical devices?

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  • FDA Finalizes Regulation Regarding Software for Medical Devices

    22 March, 2011 MasterControl

    The path to market for software that is to be used with medical devices can be rigorous. The FDA recently announced (Feb. 14, 2011) a "less burdensome path to market" according to FDA News.1 These systems (i.e, software and hardware combined) are known as Medical Device Data Systems (MDDS) and have been recently defined as low-risk devices or "Class I" devices, which definition relieves medical device professionals of the immense effort required during premarket review. However the MDDS systems

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  • FDA Considering 'Super Office' of Drug Safety

    17 May, 2011 MasterControl

    This article has been reprinted with permission from RPM Report.

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  • Hamburg Speaks about Innovation at FDLI Annual Conference

    14 June, 2011 Abby Foster, Managing Editor, FDLI

    "For FDA, innovation is not just about new ideas, but it is about making sure that those new ideas truly translate into the products and opportunities that people need and count on," Commissioner of Food and Drugs, Margaret Hamburg, explained in her opening address at FDLI's 54th Annual Conference.

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