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Pediatric Study Exclusivities Reauthorized to Encourage Development of More...
There has been an increased effort to increase pediatric testing for adult medications, due to the expense of pediatric clinical trials and parent concerns about participation. For example, an alarming...
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Clinical Study Report Tightening in New Proposed Legislation
On August 2, four members of the House of Representatives, led by Congressman Edward Markey, introduced, H.R. 6272, “The Trial and Experimental Studies Transparency (TEST) Act of 2012.” The TEST Act...
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GDUFA Guidances and Public Meeting Announced
On August 27, FDA published a Federal Register notice announcing the availability of industry guidance for generic drug user fees entitled “Generic Drug User Fee Amendments of 2012: Questions and...
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User Fee Sequestration Imminent as Congress and Obama Fails to Decide on...
On January 2, 2013, barely three months after FDA’s new user fee programs go into effect, certain mandated spending reductions, called sequestration, also may go into effect that could prevent FDA from...
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Biotechnology Innovators Lobby Congress to Restrict Use of Biosimilars
On January 28, The New York Times reported that biotechnology companies are actively lobbying state legislatures to limit access to biosimilar versions, i.e., “highly similar” versions of...
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FDA Budget Sequester Looms in Senate – Update
Written by Rachael P. McClure Other Posts By This Author With the $85 billion spending cuts now in effect, it is time for FDA and other agencies to adapt. The 2013 impact will be condensed into the...
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Biosimilars and “Pay-for-Delay” Settlements on the Table in White House’s...
Over the past months, there has been a lot of speculation (see recent blogs here , here, and here) whether the White House’s proposed budget would cause a sequester situation for FDA, resulting in...
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Compounding Bill Gains Some Traction
Compounding pharmacies are petitioning against a recent bill that would give FDA greater control over compounding manufacturers of sterile products. S.959, The Pharmaceutical Compounding Quality and...
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Compounding Pharmacy Bill Advances in Senate (Updated Again – Signed Into Law)
[Update: After unanimously passing the Senate on November 18, 2013, H.R. 3204–the Drug Quality and Security Act–is set to become law after an expected signature from President Obama. President Obama...
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Patent Troll Legislation Happens Again–Yet Another Bill
Once again, legislation aimed at deterring abusive patent litigation is making headlines. The Patent Litigation Integrity Act of 2013 (S. 1612) was introduced by Senator Orrin Hatch, R-Utah, on October...
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