News & Analysis as of

Prescription Drugs Expanded Access Programs (EAPs)

Hogan Lovells

FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

Hogan Lovells on

This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request...more

Bowditch & Dewey

Combating Opioid Abuse in the Workplace - A Proactive Approach For Employers

Bowditch & Dewey on

The opioid crisis in America remains at epidemic proportions. A study from Boston Medical Center published last week estimates that 275,000 Massachusetts residents, or 4.6% percent of all adults and children older than age...more

Verrill

Federal "Right to Try": Don't Disregard Your State Laws Just Yet!

Verrill on

How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal "Right to Try" - As discussed in our Alert of June 4, "Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers,...more

Troutman Pepper

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

Hogan Lovells

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

Hogan Lovells on

Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Bowditch & Dewey

Combating Opioid Abuse in the Workplace: A Proactive Approach For Employers

Bowditch & Dewey on

Imagine your employee “Bob” has recently missed a lot work for unexplained reasons. Bob’s coworkers notice that he sometimes “nods off” while working, and his supervisor just reported to you that Bob became enraged while...more

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