Latest News
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11 April 2013
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A new final guidance document issued by the US Food and Drug Administration (FDA) provides recommendations for the pharmaceutical industry on how to develop and conduct self-selection studies in
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Regulatory Update
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25 March 2013
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Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe have announced that a new over–the-counter (OTC) drug process for the evaluation of new and changed OTC medicines will be
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Latest News
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14 February 2013
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A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal
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Latest News
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25 January 2013
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The US Food and Drug Administration (FDA) has just approved the use of an over-the-counter (OTC) product intended to treat patients with overactive bladders, highly unusual in one regard: While the
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Latest News
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6 December 2012
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Chinese over-the-counter (OTC) manufacturer Shanghai Huhui Daily Use Chemical Products Company ('Shanghai Huhui') has been blasted by US Food and Drug Administration (FDA) inspectors for allegedly
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Latest News
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12 October 2012
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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)
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Latest News
Regulatory Update
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18 September 2012
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Australia’s Therapeutic Goods Administration (TGA) has opened a consultation on a proposed harmonized approach to the regulation of over-the-counter (OTC) medicines in New Zealand and Australia, in
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Latest News
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14 September 2012
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Regulators with the US Food and Drug Administration (FDA) have sent out a warning to consumers indicating that over-the-counter topical pain relievers such as BENGAY and Icy Hot have in some cases led
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Latest News
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12 September 2012
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Advertisements for over-the-counter (OTC) pharmaceutical products routinely discount the risks associated with a product instead of presenting the same “fair balance” approach mandated for
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Regulatory Update
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28 August 2012
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Australia’s Therapeutic Goods Administration (TGA) has released revised guidance on the evidence required to support indications made for over-the-counter (OTC)medicines.Therevised version now permits
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