[Skip to Content]
[Skip to Content Landing]
Views 555
Citations 0
Editor's Note
September 3, 2019

Evidence Supporting US Food and Drug Administration Drug Safety Communications

Author Affiliations
  • 1Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
JAMA Intern Med. Published online September 3, 2019. doi:10.1001/jamainternmed.2019.3065

The US Food and Drug Administration (FDA) is responsible for ensuring that approved drugs are safe and effective. However, the clinical trials that form the basis for FDA approval typically enroll fewer than 1000 patients and have follow-up durations of 6 months or fewer.1 Thus, most serious safety risks may only become evident after FDA approval. In fact, for approximately one-third of new drug approvals, the FDA issues a new safety communication or warning after initial approval.2

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words