News

Regulatory Update | 18 March 2013

Two New Indian Advisory Committees to Generate New Guidelines for Clinical Trials, Drugs

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The Drugs Controller General of India (DCGI) for the Central Drugs Standard Control Organization (CDSCO) has requested input from the public regarding two newly formed independent advisory Read More...

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Latest News | 12 October 2012

Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions

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Australia's Therapeutic Goods Administration (TGA) has released responses submitted to the agency regarding a draft guideline set to change the way the regulator oversees over-the-counter (OTC) Read More...

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Latest News | 9 October 2012

Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

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Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the Read More...

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Latest News | 26 July 2012

EMA Releases Additional Pharmacovigilance Guidelines, Announces Closure of Committee

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The European Medicines Agency (EMA) announced today (26 July) the release of two additional guidelines on good pharmacovigilance practices (GPhVPs) and the shuttering of its Pharmacovigilance Working Read More...

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Latest News | 10 July 2012

Proposed Legislation Would Require FDA to Develop Guidelines to Ensure Scientific Quality

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A bill proposed in late June 2012 by a bipartisan group of congressmen would require all federal agencies, including the US Food and Drug Administration (FDA), to develop guidelines to ensure Read More...

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Latest News | 9 January 2012

EMA Issues Guidelines on Development of Antibacterials

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The European Medicines Agency (EMA) today released a guideline titled, Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. The document was approved last Read More...

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