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4 March 2013
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Talk to a regulatory professional—any regulatory professional—involved in the regulation of healthcare products in the US, and one thing you're unlikely to hear is an explanation of how simple the
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Latest News
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22 February 2013
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Ophthalmic products manufacturer Alcon Research has been hit with an untitled letter by the US Food and Drug Administration (FDA) regarding its Pataday allergy eye drops, which regulators claim were
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16 October 2012
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The US Food and Drug Administration (FDA) has taken aim at another of the cosmetic industry's giants over the use of marketing claims reserved for approved pharmaceutical products—its fourth warning
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2 October 2012
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The US Food and Drug Administration (FDA) is increasingly cracking down on the marketing claims used by some cosmetic companies, firing off at least three warning letters in as many weeks regarding
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Latest News
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11 September 2012
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When does a cosmetic product become a drug? When it’s marketed as having advanced features that alter the body's cellular state, explained the US Food and Drug Administration (FDA) in a warning letter
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25 June 2012
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[Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not
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Regulatory Update
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24 April 2012
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Australia's Therapeutic Goods Administration (TGA) is seeking comment from interested parties on draft guidance Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and
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Latest News
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23 April 2012
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Australia’s Therapeutic Goods Administration (TGA) announced 23 April it is looking for comments on its draft guideline outlining the types of evidence needed to support indications made for low-risk
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