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Regulatory Submissions

  • Emmaus Medical’s New Drug Application for Sickle Cell Disease Recommended for Approval by FDA

    Posted on 6/7/2017 4:42 PM

    MMS Holdings Inc. (MMS) has been providing clinical data, writing and regulatory submission support for Emmaus since 2015...

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  • Are You Ready for the Upcoming eCTD Requirements in US and EU?

    Posted on 6/1/2017 2:49 PM

    FDA and EMA are requiring eCTD submissions for many application types in the next year. See the table...

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  • The Critical Role of a Regulatory Operations Specialist in a Successful Submission: 10 Key Success Factors

    Posted on 3/25/2015 12:17 PM

    For flawless submissions rooted in quality from the early stages of conception through successful execution and submission, a Regulatory Operations Specialist (ROS) can be considered the Captain of the Ship. Their role is not as simple as many consider it to be. A submission is not about attaching pre-written documents to an email and hitting the “Send” button on the FDA Gateway. It involves strategy and efficient operational skills for compilation, and minimizing the chances of errors that ca

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  • Whitepaper Preview: 505(b)(2) NDA: Navigating the Regulatory Pathway

    Posted on 8/5/2014 3:55 PM

    Review and Approval of new drugs by the Food and Drug Administration (FDA) is the foundation of drug safety in the United States. Despite this, a number of prescription and over the counter drugs are marketed in the US without FDA approval, often unknown to the patients and health care providers who take and prescribe them. Typically, these are drugs that came to the market prior to the monumental 1962 Food and Drugs Act amendment and, for a variety of historical reasons, have not met the mode

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  • Case Study: MMS Support for Entire Women's Health NDA

    Posted on 7/8/2014 4:19 PM

    Challenge: Sponsor Needed NDA Support for Women's Health Compound A small company in partnership with a mid-sized Japanese pharmaceutical company needed full planning, operations and NDA submission support for a women's health compound. The full scope of services included project management, a timeline for all operational tasks and the development of the overall submission. MMS was responsible for preparing the final pivotal CSR and integrated analysis plan, converting and integrating clinica

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  • Prescription to Over the Counter Switch

    Posted on 7/1/2014 4:22 PM

    There are many regulatory considerations an organization should evaluate when transitioning a prescription drug to an Over the Counter (OTC) drug in the United States. Is the product safe in the OTC environment? Do the drug’s benefits and risks remain favorable? Does the potential for misuse and abuse remain low as an OTC drug? Can consumers adequately self-diagnose? Can consumers appropriately select and use the product in accordance with product labeling? Do users need the assistance o

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  • Pharmaceutical Regulatory Writing and Submissions 2013: Conference Recap and Highlights

    Posted on 3/31/2013 11:49 AM

    The 2nd annual Pharmaceutical Regulatory Writing and Submissions conference was held in Alexandria, VA on May 6th and 7th, and provided an exciting opportunity to exchange information and experiences with other industry leaders in medical writing and regulatory submissions. The conference covered a broad range of topics from content authoring, writing and submissions technologies, and complexities and strategies for global submissions. With presentations varying from case studies to panel discus

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  • Accelerated Approval of Oncology Drugs: Overnight Successes

    Posted on 12/20/2012 9:33 AM

    The Newsweek headline on May 27, 2001 announced “A Cure for Cancer?” Just weeks before this headline, the United States Food and Drug Administration (FDA) announced the accelerated approval of a new powerful anti-cancer drug after a review period of only two and a half months, making it the fastest FDA-approved cancer drug in history. Scientists and physicians were thrilled that one of the first targeted tyrosine kinase inhibitors, Gleevec, demonstrated efficacy in patients with chronic myeloge

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