RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

The RAPS store will be under maintenance Saturday, 6 June between 6 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > FDA Says it Wants to Make Anticoagulants, Opioids and Diabetes Drugs Safer for Patients

FDA Says it Wants to Make Anticoagulants, Opioids and Diabetes Drugs Safer for Patients

Posted 24 February 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) wants to fund studies that will help it increase the safety of pharmaceutical and biological products even after they've been approved, it has announced.


The announcement was made on 21 February 2014 as a technical amendment to an earlier "broad agency announcement"-essentially a wish list of regulatory science initiatives FDA said it planned to spend as much as $50 million on in the coming months.

The original announcement called for spending in eight areas:

  1. the modernization of toxicology testing with the intent of enhancing product safety
  2. the stimulation of innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes
  3. supporting new approaches to the improvement of product manufacturing and quality
  4. ensuring FDA has the capacity to evaluate innovative emerging technologies
  5. harnessing diverse data through information sciences to improve health outcomes
  6. facilitating the development of medical countermeasures to protect against threats to US health and security
  7. strengthening social and behavioral science at FDA by enhancing public and industry understanding
  8. strengthening the global product safety net

Examples of projects included the development of new models to predict adverse events, the identification of new biomarkers, and even new ways of communicating with members of industry and the public.

New Studies Wanted

Now FDA wants to add an additional area: Ways of improving the safety of post-approval drug use.

The prospective study or studies would "develop innovative methods to better understand and reduce the occurrence of adverse events in post market use of drugs," FDA wrote.

FDA said it was particularly interested in studies to limit hypoglycemia in diabetics, serious bleeding events in patients on anticoagulants (such as Xarelto or Warfarin), and chronic pain patients on opioid therapy. The latter are often at higher risk for developing addictions or abusing the medication.

Other areas are welcome for study as well, FDA added.

FDA said its desired approaches aren't so much seeking new science as they are new approaches, such as the use of "innovative messaging strategies, electronic health records, mobile technologies, clinical studies or educational campaigns."

Study proposals are due to FDA by 22 May 2014.


FBO Notice

Tags: studies

Regulatory Focus newsletters

All the biggest regulatory news and happenings.