The Food and Drug Administration (FDA) issued a new rule this week that will clarify what and when safety information must be reported during clinical trials of investigational drugs and biologics.

The new rule, which goes into effect on March 28, 2011, replaces current practices of reporting any and all adverse reactions experienced a during clinical trials once the trial is complete. The new rule requires companies sponsoring new drugs or medical products to report within 15 days any safety issues, such as findings that suggest a significant risk to study participants and higher-than-expected adverse events to the treatments.

The new rule also lifts the requirement for drug companies to report all serious adverse events, such as events that had to do with underlying disease and not the drug itself. The FDA instead is offering guidelines on when a single event needs to be reported.

The rule also requires safety information be reported on serious adverse events from bioavailability studies, which determine what percentage and at what rate the drug is absorbed by the bloodstream, as well as bioequivalence studies, which determine whether a generic drug has the same bioavailability as the brand name drug.

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said Rachel Behrman, M.D, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.”

According to the FDA, the new rule revises definitions and reporting standards so that they are more consistent with two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences. The changes are designed to help ensure harmonized reporting of globally conducted clinical trials. 



We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Beasley Allen attorney Danielle Mason warns of...

Could your medication be harming you? New drugs are approved by the FDA before they go to market, to...

Blood pressure medication linked to fetal injury, death

Women who are pregnant should avoid drugs used to treat hypertension, or high blood pressure, because...

Topamax linked to birth defects

Women of childbearing age who take the prescription medication Topamax should be aware that new studies...

Buyers Beware: Generic drug makers not required to...

A Supreme Court ruling on June 23 reversed separate U.S. appeals court rulings that would have held...

Popular diabetes drug linked to cancer

The FDA is evaluating Actos for a possible link to bladder cancer. Preliminary results from a long-term...

SSRI antidepressants increase risk of birth defects

A new study has verified that antidepressants known as selective serotonin reuptake inhibitors (SSRIs)...

Wonderful to work with

Beasley Allen did a great job with my case. They were wonderful to work with. They were available by phone when I needed them, treated me with the utmost respect and worked hard on my behalf. If a need arises in the future, I would definitely call on them again.

—Geraldine