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FDA Postpones Advisory Committee Review of Celltrion’s Remicade…
Celltrion will have to wait longer than expected for FDA's Advisory Committee to review its application for Remsima, a …
Physician Payments Sunshine Act: CMS Holds Data Submission Q&A
Yesterday, CMS’ Open Payments team held an informal question and answer session. Doug Brown, director of the data sharing and…
FDA seeks $4.9 billion for FY 2016; Commissioner Hamburg Reflects on…
Dr. Margaret Hamburg will step down from her post as Commissioner of the FDA next month. Hamburg and the FDA were busy…
FDA Loses Orphan Drug Exclusivity Battle, But Doesn’t Plan To Change Its…
Earlier this year, we noted the Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since…
Polaris adds industry veteran Vincze, promotes three partners, continues…
Polaris, the global leader in consulting and technology for life science healthcare law compliance, recently announced several…
Rep. Paulsen Introduces Bill to Repeal Medical Device Tax
Rep. Erik Paulsen (R-Minn) this week introduced a bill to repeal the 2.3 percent tax on medical device sales. The…
Thursday, January 15: Open Payments Question and Answer Session
The Centers for Medicare and Medicaid Services (CMS) will be hosting a call next Thursday, January 15, 2015 for an Open…
New Bill Would Exempt Low-Risk Medical Software and Apps from FDA…
Bipartisan legislation drafted by Senators Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.) looks to exempt electronic health…
December 11 Webinar: Drug Supply Chain Security Act: How to Get Ready…
On Thursday, December 11, the law firm Arnold and Porter will be hosting a webinar: “Drug Supply Chain Security Act…
NIH Issues Clinical Trial Transparency Proposal; Expands Submissions to…
Yesterday, the Department of Health and Human Services and the National Institutes of Health (NIH) proposed to “increase the…