Monthly Publications
In Depth
Subscribe Now
In Depth
coverage of timely
Life Science
Compliance issues
Subscribe Now
Browsing Category
FDA
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…
Drug and Device Companies Critical Of FDA’s Guidance Development
Recently, the Combination Products Coalition ("CPC") wrote a letter to Leslie Kux, FDA's Assistant Commissioner for…
21st Century Cures Update: Ebola Hearing October 16, FDA’s LDT Draft…
This past July we wrote about the 21st Century Cures initiative and its efforts to bridge the gap between medical advances and the…
FDA Releases Cybersecurity Guidance: “Content of Premarket…
Late last week, the Food and Drug Administration released its “cybersecurity” guidance, outlining recommendations that…
FDA Reopens Comment Period For Social Media Guidance; PhRMA and Washington…
FDA is reopening the comment period for its two controversial draft social media guidances. The decision comes in response to…