Drug Promotion During Pandemic: Website Links To Telemedicine Prescribers Require Caution
Executive Summary
Growing trend of linking product websites to telehealth services raises regulatory concerns. Virtual interactions with healthcare providers might necessitate new FDA guidance, lawyers note at FDLI annual meeting.
You may also be interested in...
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
Biopharma Industry Sharply Divided Over Supreme Court Antibody Patent Brawl
Big biologic makers line up on opposite sides of dispute between Amgen and Sanofi over whether Amgen’s Repatha patents cover analogous antibodies with the same functional characteristics.
After Xtandi, Will Government Ever Seek March-In Rights Over Drug Pricing?
Market availability of Xtandi, not its cost, is the issue, NIH says in denying petition for government to invoke march-in rights to patents on the prostate cancer drug. But Biden administration makes two other same-day moves that could leave march-in advocates with some hope.