1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Expanded Access: Reducing The Contract Delay

 
• By Derrick Gingery

While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.

Timetable at the Central Station
Contract negotiations between the patient, provider and sponsor are among the most time-consuming portions of expanded access process, one company representative said. • Source: Shutterstock

Efforts to streamline the US Food and Drug Administration's expanded access program may be hindered by legal protections that the drugs' sponsors require of prospective patients' providers.

Agency officials have been trying to reduce the time and burden necessary for patients and physicians to gain access to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.