U.S. News & World Report Ranks HP&M as Top Tier FDA Law Firm for 2017 - 7th Year in a Row!
HP&M's FDA Law Blog once again chosen as an ABA Journal's Blawg 100.
Recent FDA Law Blog Entries from www.fdalawblog.net
An Extra Dollop of Ketchup is Not a Crime! Or is it? Confusion Over Calories on Menus Continues
What to Do When You Receive a DEA Order to Show Cause
FDA Finalizes Guidance on When to Submit a 510(k) for a Change to an Existing Device
FDA Denies Millennium Petition on Generic VELCADE and . . . Yada, Yada, Yada . . . Permits ANDA Labeling “Carve-in”/“Carve-up”
Articles and Presentations
Court deals blow to mysteriously named whistleblower, blowing off precedent
October 17, 2017
When it comes to software as a medical device, FDA acknowledges that new technology no longer fits the old regulatory paradigm
September 19, 2017
Is the 510(k) process as worthless as the federal courts seem to believe?
August 8, 2017
The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials
July 27, 2017
Congress Seeks a Statutory Fix to Stymied Off-Label Discussions
May 2, 2017