Expanded Access
Expanded Access
Access to Investigational or Unapproved Medicines
Irvine Labs conducts clinical trials to assess the safety and efficacy of investigational therapeutics. The data acquired from the clinical trials is used to support and obtain approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Patient access to investigational medicines
In some cases, patients who have completed clinical trials, or are not able to participate in clinical trials, and face serious or life-threatening conditions, may be allowed special access to investigational medicines outside a clinical trial setting.
Laws Regulating Expanded Access
Depending on the country, and in some cases, State by State, the laws and regulations controlling Expanded Access or Early Access to investigational medicines vary. Some regulations call this type of use Compassionate Use, or Emergency Use.
These allowances do not apply to using currently marketing medicines for indications outside their approved label.
Individual Patient Access
A qualified healthcare professional may request to use an investigational medicine for a single patient, due to current therapies not being sufficient to treat their patient. The request may or may not require approval from a government agency.
Multiple Patient Access
Irvine Labs or a group in collaboration with Irvine Labs may request from the FDA or applicable national health authority that an investigational medicine may be made available to a specific group of patients based on an unmet medical need under the Compassionate Use or Expanded Access programs in the UE and US.