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FDA
“New Chemical Entity Exclusivity Determinations for Fixed-Combination…
The Food and Drug Administration (FDA) recently finalized guidance which allows fixed-combination drugs consisting of at…
FDA Regulatory Requirements, Enforcement Activity Have Increased Despite…
We frequently cover FDA regulations—proposed rules, FDA explanations, the role of collaboration between industry and FDA…
FDA Solicits Comments on Best Practices for Communication Between the…
At the end of October, the U.S. Food and Drug Administration (FDA) announced it is seeking feedback to improve communication with…
Ebola Update: New Bill to Fast Track Ebola Treatment; FDA Focuses on…
On Wednesday, November 12, HHS Secretary Sylvia Burwell and Homeland Security Secretary Jeh Johnson will appear before the Senate…
FDA-CMS Parallel Review Process Brings Its First Device to Market
Getting a medical device to market is not easy. The Food and Drug Administration (FDA) approval process alone can take…
Don’t Delay: FDA Finalizes Guidance on “Circumstances that…
An FDA inspection consists of a “careful, critical, official examination of a facility to determine its compliance with…
FDA Responds to Zohydro Painkiller Criticism
Last year, the Food and Drug Administration (FDA) approved an opioid pain relief drug called Zohydro. Zohydro is an…
Drug Shortages Update
Thomas Sullivan
Over the years we have discussed the impact of drug shortages on healthcare in the United States. With…
Mining Social Media for Adverse Events
In February, the FDA released a Request for Proposal asking firms to help the agency monitor social media activity for…
Can Silicon Valley and FDA Work Together?
Silicon Valley has been interested in the healthcare industry for many years. Genetic testing startup 23andMe’s battle with the…