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BioWorld - Monday, January 12, 2026
Home » Topics » Regulatory

Regulatory
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FDA retains 'well-defined' restriction in special 510(k) final

Sep. 13, 2019
By Mark McCarty

Health of U.S. patent system in the eye of the beholder

Sep. 13, 2019
By Mari Serebrov
Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
Read More

Product regulatory actions for Sept. 12, 2019

Sep. 13, 2019

Health of U.S. patent system in the eye of the beholder

Sep. 13, 2019
By Mari Serebrov
Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
Read More

FDA approves Xeris' Gvoke, first ready-to-use stable liquid glucagon for severe hypoglycemia

Sep. 12, 2019

Product regulatory actions for Sept. 11, 2019

Sep. 12, 2019

Budget restrictions on the way for medical devices in France

Sep. 11, 2019
By Bernard Banga

Regulatory front

Sep. 11, 2019

Product regulatory actions for Sept. 10, 2019

Sep. 11, 2019

Regulatory front

Sep. 10, 2019
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