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    Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs

    A number of drugmakers are calling on the US Food and Drug Administration (FDA) to be more flexible with sponsors in developing guidance on safety assessments for investigational new drug (IND) applications, according to comments published Wednesday on the draft document. The draft guidance from December calls on sponsors to create a safety assessment committee (SAC) to review safety information in a clinical development program and make recommendations to the sponsor ...
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    The Art of Saying Yes and No

    ‘Yes’ and ‘no’ are two simple words in the English language, but they generate a vast array of mind-boggling complexities when used incorrectly—whether intentionally or unintentionally. How many of us have said yes when we actually wanted to say—or should have said—no, and vice versa? Imagine you are invited to party you have no desire to attend, and inside you are screaming “no,” but you say yes because you do not want to offend the host or wish others to think y...
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    FDA Offers Draft Guidance on IND Safety Reporting

    For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday. The new guidance on IND safety reporting follows previous guidance on Safety Reporting Requirements for INDs and BA/BE Studies from 2012 and contains specific details on: The composition and role of a safety assessment ...
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    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...
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    FDA Warns California Ophthalmologist Again Over Clinical Trial Violations

    For the second time since 2000, the US Food and Drug Administration (FDA) has sent a warning letter to a Newport Beach, California-based ophthalmologist over objections to a clinical trial run by him. The latest letter, released Tuesday, claims that Dr. Thomas Tooma of the NVISION Laser Eye Centers ran a clinical trial at seven sites with an unapproved drug without first submitting an investigational new drug (IND) application to FDA as required by law. “Your investig...
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    Chicago Workshop to Help Regulatory Pros Communicate More Effectively

    Most regulatory professionals do not have a background—or often any training at all—in communications. Yet they are called upon every day to be effective communicators. Whether it’s communicating with their peers on a regulatory team, colleagues in other areas within their organizations, upper management, regulators, researchers, contractors or others, regulatory pros need to be clear, establish credibility and influence people in different disciplines and at many d...
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    How to be a Regulatory Leader

    Increasingly, regulatory professionals need to be effective leaders. Not only are they leading regulatory departments and cross-functional work groups, they also are being called upon to play key roles on corporate and organizational leadership teams. RAPS’ Scope of Practice Study shows that regulatory professionals now spend up to a third of their time working on strategy or business-related duties. Recognizing the value regulatory experts bring to the C-suite, s...
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    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
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    23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

    Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year. Background FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation , Section 312 (21 CFR 312). The section ...
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    FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014

    Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator. Background The data relate to FDA's "expanded access" program—sometimes called its "compassionate use" program—which was created to allow a pathway for terminally or critically ill patients to obtain access to drugs they...
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    FDA Wants Input on How to Improve Clinical Trials Process for Industry

    The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process. In an announcement in the Federal Register on 28 October 2014, FDA said it had established a docket at regulations.gov to allow it to receive comments from industry, the public and other organizations interested in formulating "best practices for communication between FDA and investigational new drug appl...
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    FDA Revises Policies on Obtaining Informed Consent in Clinical Trials

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent. Informed Consent: The Basics As FDA explains in the draft guidance, Informed Consent Information Sheet , when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this...