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    UK Regulator Touts its Involvement in Domestic Manufacturing Site

    The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is once again touting its efforts to bolster manufacturing innovation, releasing a case study explaining its role in the redevelopment of a local manufacturing site. Background In 2013, MHRA launched its Innovation Office, with the goal to provide advice and assistance to companies working on novel treatments or manufacturing processes. The Innovation Office encourages companies to contact them e...
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    FDA Plans Studies into Problems Affecting Complex Generic Drugs

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is preparing to fund studies to develop models to better evaluate generic drugs, including modified-release drugs and several popular oral anticoagulants. Overview The study , announced on 24 March 2015 on the federal government's grants.gov website, is intended "to develop pharmacometric modeling and simulation tools for generic drug substitutability evaluation and post marketin...
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    Leader Sought for FDA's Influential Office of Device Evaluation

    The US Food and Drug Administration (FDA) is seeking a permanent leader for its medical device-focused Office of Device Evaluation (ODE), the division responsible for reviewing nearly all medical devices marketed in the US. The office was most recently run by Christy Foreman, who stepped down in September 2014 to take a new role within FDA's new Center for Tobacco Products. Bill Maisel, deputy director for science and chief scientist at FDA's Center for Devices and R...
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    Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions

    In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act . Background India’s patent system has been a source of frustration for western drug makers, who have argued for intellectual property (IP) reform in the country. India is also listed on the US Trade Repre...
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    FDA Seeks New Top Press Official for its Office of Media Affairs

    The US Food and Drug Administration (FDA) has started its search for a new leader for its Office of Media Affairs , better known simply as FDA's Press Office. In a job notice posted on 2 March 2015, the agency said it's looking for a new assistant commissioner for media affairs—a position which has long been in a state of flux. The office is currently overseen by Acting Assistant Commissioner Heidi Rebello, who took over from former Acting Assistant Commissioner Eric...
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    Facing Key Challenges, FDA's Office of Generic Drugs Seeks Deputy Director

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), fresh off the appointment of a permanent director last month, is hoping to hire someone to act as the office's second-in-command. In a notice posted to the USA Jobs website this week , OGD, which oversees the regulation of all generic pharmaceutical products in the US, said it is trying to fill an open position for deputy director of OGD. The position would be responsible for helping to plan, m...
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    Influential FDA Drug Policy Office Gets New Leader

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has announced the hire of a new leader for its Office of Medical Policy (OMP), an influential office tasked with developing the agency's pharmaceutical policies. Background The 150-person office is influential within FDA, and describes itself as the "driving force" behind drug policy development at the agency. Major policies recently developed and implemented by OMP include FDA's ...
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    FDA's Advertising Regulators Cite Drug Company in First Warning of 2015

    For the first time this year, the US Food and Drug Administration's (FDA) pharmaceutical advertising watchdog, the Office of Prescription Drug Promotion (OPDP), has issued a warning to a company for allegedly trying to promote a product for uses for which it had not received FDA approval. The warning, known as an "Untitled Letter," is less serious than the agency's more formal Warning Letters in that it does not threaten immediately regulatory enforcement action if a com...
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    Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

    The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic pharmaceutical industry. Background As Focus has previously reported, FDA issued a Federal Register notice in August 2014 announcing that it planned to hold a meeting to discuss the implementation of the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administr...
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    FDA Hires World-Renowned Cardiologist to Oversee Medical and Regulatory Policy

    One of the world's top cardiologists is set to join the US Food and Drug Administration (FDA) next month to oversee four of its largest regulatory divisions, FDA Commissioner Margaret Hamburg has announced. In a 26 January 2014 announcement, Hamburg said FDA had appointed Robert Califf as deputy commissioner for Medical Products and Tobacco. Califf is a familiar figure to many within the life sciences field. He is currently the director of the Duke Translational Medici...
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    On a Hiring Spree, FDA Hires Almost 1,000 New Generic Drug Regulators

    If you're a regulatory professional whose job includes working with the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), you might be seeing some new names and faces in your interactions with the agency—about a thousand of them, in fact. In an update last week to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said OGD had succeeded in hiring 923 new employees as of October 2014. OGD has been on a hiring...
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    Another Reorganization for CDER: Its Office of Management

    The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is already off to a busy start this year, having released new long-sought functions on its website , launched its new Office of Pharmaceutical Quality (OPQ) and hired a permanent director for its Office of Generic Drugs . The changes, it seems, aren't stopping there. Last week, CDER also announced a reorganization of its Office of Management in the hopes of streamlining its approach ...