Brian J. Wesoloski

FDA Issues Draft Guidance on Reporting Drug Sample Distribution Information under the Patient Protection and Affordable Care Act
Kyle Sampson,Brian J. Wesoloski, April 4, 2012
On March 28, 2012, the Food and Drug Administration (“FDA” or “Agency”) announced the availability of a draft guidance for industry titled “Compliance Policy on Reporting Drug Sample Distribution Information Under the Affordable Care Act” (“Draft...

FDA Issues Three Draft Guidances on Biosimilar Product Development
Heather D. Banuelos,Adele M.K. Gilpin,Gary C. Messplay,Allison Reschovsky,Brian J. Wesoloski, February 16, 2012
On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued the following three draft guidance documents to assist industry in developing biosimilar products:

FDA Requests Comments on Draft Guidance on Responding to Unsolicited Requests for Off-Label Information, and on Certain Other Policies Regarding Off-Label and Pre-Approval Promotion
D. Kyle Sampson,Brian J. Wesoloski, December 30, 2011
In two separate announcements, the Food and Drug Administration (“FDA” or “Agency”) is requesting (1) comments and suggestions regarding a draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices...