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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…
Biomet Settles for $6 Million Over Alleged Kickbacks
EBI LLC, a subsidiary of Biomet, Inc. has agreed to a $6 million settlement with the U.S. Department of Justice to…
Ebola Update
Trends-in-Medicine is offering updates on Ebola, which recently has shown up inside the United States. We don’t normally…
GDUFA Update: FDA Seeks Public Comment on Its Guidance Documents
On September 17, FDA hosted a public hearing on the Generic Drug User Fee Amendments of 2012 to solicit public comments on its…
FDA Grants Citizen Petitions To Clarify Its Stance on Truthful,…
This summer, in a letter to counsel, the Food and Drug Administration (FDA) granted citizen petitions that asked the agency to…
Sales Rep Access to Doctors At All Time Low: “Accessible Prescribers” Down…
A new report by ZS Associates looked at call reports for more than 200 pharmaceutical sales teams and found that reps’…
Physician Payments Sunshine Act: Physician and Teaching Hospital…
The Centers for Medicare and Medicaid Services (CMS) has just announced that physicians and teaching hospitals can begin…
Stakeholders Argue FDA’s New Reprint Guidance Is Unworkable and “Omits Any…
In March, we covered FDA's revised guidance for manufacturers seeking to distribute scientific journal articles that…
FDA Guidance for Industry: Fulfilling Regulatory Requirements for…
Jan. 13, 2014: At long last, the US Food and Drug Administration (FDA) has released social media guidance for pharmaceutical and…