Heather D. Banuelos

FDA Issues Draft Guidance for Review of DTC Television Ads
Heather D. Banuelos,Gary C. Messplay,Allison Reschovsky, March 20, 2012
On March 12, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance titled “Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad PreDissemination Review Program.” The draft guidance explains how FDA...

FDA Issues Draft Guidance on Drug-Shortage Reporting
Heather D. Banuelos,Sharon M. Bradley,Gary C. Messplay, February 24, 2012
On February 21, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”) made available a new draft guidance document titled “Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage.” The draft guidance aims...

FDA Issues Draft Guidance Regarding Safety Data Collection in Late-Stage Premarket and Postapproval Clinical Studies
Heather D. Banuelos,Sharon M. Bradley,Gary C. Messplay, February 17, 2012
On February 10, 2012, the U.S. Food and Drug Administration (“FDA” or “the Agency”) announced the availability of a new draft guidance document entitled “Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical...