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    FDA guidance covers frequently asked CMC questions for generic drugs

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday issued a draft guidance that provides generic drug applicants with answers to commonly asked questions in the drug quality area. The new guidance is designed to provide an immediate response to such questions to reduce the number of controlled correspondence on identical topics.   The guidance, which is in a question-and-answer format, covers FDA’s policies on quality...
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    FDA Revises Priority ANDA Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA). As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at leas...
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    FDA Drafts Guidance on Controlled Correspondence Under GDUFA II

    The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II). When finalized, the 20-page guidance will replace guidance from September 2015 from GDUFA I. The GDUFA II commitment letter defines complex controlled correspondence as correspondence related to: Evaluation of clinical content Review of bioe...
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    Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials

    In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making. "For much, and perhaps most, of modern medical practice, RCT-based data are lacking and no RCT is being planned or is likely to be completed to provide evidence for action. This 'dark matter'...
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    Priority Generic Drug Reviews: New FDA Draft Guidance

    In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...
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    When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains

    The US Food and Drug Administration (FDA) on Monday released a manual of policies and procedures (MAPP) outlining how its Center for Drug Evaluation and Research (CDER) staff consult with Controlled Substance Staff (CSS) on abuse potential and dependence liability. Since 2000, CDER and CSS, which fulfills a unique role within FDA under the authority of the Controlled Substances Act (CSA) of 1970, have collaborated to evaluate all new drug applications (NDAs), abbrevia...
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    FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

    The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances. The comments received will be considered in preparing the US position on these proposals for a meeting of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria,...
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    When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the non-inferiority margin and how to test the non-inferiority hypothesis. The 56-page guidance, which finalizes a draft from 2010 and supersedes the 2010 guidance known as "Antibacterial Drug Products: U...
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    Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Posts Guide to Online Application Form for High-Risk IVDs TGA has released a guide to using its online application form for Class 4 in-house in vitro diagnostic (IVD) devices. In keeping with recent guides created by TGA, the IVD document is a comprehensive walkthrough of the process of applying online for devices that fall into the highest-risk category. Class 4 IV...
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    New Law Redefines When Controlled Substances are Officially Approved

    Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved. The new law, known as the Improving Regulatory Transparency for New Medical Therapies Act, sets new deadlines for the US Drug Enforcement Administration (DEA) to schedule controlled substances, like opioids and other drugs that have the potential to be abu...
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    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
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    FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns

    The US Food and Drug Administration's (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments. Background Initially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act , and was intended to address formal questions posed to FDA prior to the generic drug review process and to clari...