PTC Therapeutics was ordered by a U.S. District judge to supply a drug still in Phase II trials to Jacob Gunvalson, who has muscular dystrophy. Despite alleged promises to do so, PTC declined to enroll him in a trial or obtain a treatment IND under 21 CFR 312.34. Should changes be made to compassionate use policies in light of this case?
In a new BioWorld Today and Medical Device Daily audio briefing, clinical trial expert attorney Clint Hermes will examine the latest developments in compassionate use so that you can maximize legal risk and stay compliant.
"Compassionate Use: Changes You Should Make Following Gunvalson et al. v. PTC Therapeutics" is just $199 per listening site. Scheduled for October 6th, from 2-2:45 p.m., it includes presentation handouts and a Q&A session with the speaker. A briefing CD (MP3 format) is also available. Please call 800-688-2421 or 404-262-5474 and mention briefing code T08514.