Galderma and FDA, a partnership

How Galderma partners

By law, Galderma is required to report safety information to regulatory authorities according to specific timelines. Following approval, Galderma continues to inform health authorities on the safety of our products through the submission of expedited individual case safety reports, periodic aggregate safety reports, clinical study reports, and other relevant communication on safety issues in a timely manner consistent with applicable regulations. Galderma's investigator must also report adverse events to and promptly communicate with regulatory authorities when we become aware of any new safety information that might influence the evaluation of a product's benefits and risks.

We routinely communicate safety information to regulatory authorities as a part of our expedited and periodic reporting and risk management activities. The expedited and periodic reporting is collected through adverse event reports from all over the world and enters the information into a common electronic database to further evaluate the safety and risks of our products.

Regulatory agencies and pharmaceutical/medical device manufacturers use a risk assessment and decision-making process to preserve patient safety. This process depends on the reporting of adverse events to identify potential risks of marketed medications and medical devices, particularly extremely rare events that would not have necessarily been identified in clinical trials. Often, infrequent side effects can only be observed after a medication or a medical device has been approved and used across a large, diverse patient population for an extended period of time.

For this reason, it is important to report adverse events once a product is marketed. The reporting of all non-serious and serious events associated with a medication or medical device, regardless of severity or outcome, enables manufacturers to ensure that health care providers have the best understanding we have about the risk profile of a medication or medical device.

Galderma and regulatory agencies rely on voluntary reporting of adverse events so that patients can be better served.