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2 April 2013
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The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required by FDA, so anyone working on drug regulatory submissions needs to understand the format well.
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27 March 2013
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A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the
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21 March 2013
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The US Senate has approved a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees
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15 February 2013
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US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration
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15 February 2013
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Exit interviews have long been a tactic of companies looking to collect and understand the opinions of staff, usually when they depart. But now a similar tactic is being proposed by the US Food and
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19 December 2012
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A new draft guidance document published by the US Food and Drug Administration (FDA) is intended to assist sponsors in the application of electronic regulatory submissions for products regulated by
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28 November 2012
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The US Food and Drug Administration (FDA) is making it a whole lot easier to keep track of the agency’s planned activities and projects coming out of the FDA Safety and Innovation Act (FDASIA), a
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5 November 2012
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Hurricane Sandy left much of the US' eastern seaboard battered and flooded after coming ashore in late October, and the damage and delays it caused are having regulatory implications, the US Food and
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30 October 2012
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Renewed every five years, the Prescription Drug User Fee Act (PDUFA) is one of the single most important and successful pieces of legislation affecting both the US Food and Drug Administration (FDA)
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24 September 2012
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Both chambers of Congress have now passed a continuing resolution that would keep the government's—and the US Food and Drug Administration's (FDA)—budget at existing fiscal year 2012 levels, averting
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