Drugs

FDA Adds Patent Submission Dates to Orange Book

FDA says it is including patent submission dates in the Orange Book prospectively. FDA began patent submission date data collection in 2013 and the latest Orange Book contains patent submission dates since then, according to attorneys Sara Koblitz and Kurt Karst (Hyman, Phelps & McNamara) in a FDA Law Blog post.

“This is a big and important change to the Orange Book,” the attorneys write. “Now applicants will have a much clearer picture on timely listed patents and whether listed patents require certification. Knowing the submission date will also help clarify whether a listed patent will trigger a 30-month patent litigation stay, otherwise delay approval of a pending application, or require a carve-out.”

Previously, according to the post, patent submission date information was available only by contacting the Orange Book staff, making it difficult for generic companies to determine if a patent was late-listed, relisted, or properly listed, and therefore difficult to know whether an ANDA applicant needed to include a patent certification or needed to update an application with an amended certification.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome