Latest News
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17 June 2013
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Consumers and industry alike have long been able to look up the approved labeling for prescription medication using the US Food and Drug Administration's (FDA) Drugs@FDA online database. Starting
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21 May 2013
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Earlier this year, the US Food and Drug Administration (FDA) said it wanted industry's input regarding how it could establish standardized—and mandatory—labeling for medical devices, postulating that
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13 March 2013
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The US Food and Drug Administration (FDA) has published a new final guidance document on the criteria that sponsors of new and abbreviated drug applications (NDA/ANDA) should use to evaluate tablet
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8 March 2013
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The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the labeling of medical products not made with natural rubber latex (NRL).NRL is found in numerous
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Latest News
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13 December 2012
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A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility.The company, Performance Products Inc (PPI), was accused of
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3 July 2012
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The US Food and Drug Administration (FDA) has released new draft guidance pertaining to over-the-counter drug products containing acetaminophen, saying it will allow exceptions to a labeling rule
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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Australia's Therapeutic Goods Administration (TGA) is seeking comment from interested parties on draft guidance Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and
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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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19 April 2012
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After the Supreme Court of the US ruled in its controversial Pliva v. Mensing decision that generic pharmaceutical manufacturers are not liable for tort claims based on labeling because federal law
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21 March 2012
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A new study in the British Medical Journal has found that limited health literacy was associated with higher rates of death among study participants.The study tracked nearly 8,000 patients over the
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