Our scientists are leveraging the latest technologies and scientific advances to discover and develop new medicines.
Conduct of Clinical Trials & Postmarketing Commitments
The clinical development process is divided into phases that help us learn important information in a step wise fashion. Depending on the drug and disease being studied, the process might begin with a single dose in healthy volunteers. For other disease states such as cancer, the studies may start with patients and allow dosing for as long as the patient is getting benefit from the drug. There is not a single method that can be used for all drugs and diseases. However, there are some general steps that are important for the development of all drugs depending on the trial participants and the aspects of the drug being assessed. Clinical trials can take place prior to the approval of a drug (premarket) and after the approval of a drug (postmarket).
- Phase 1 studies are the first time an investigational drug is given to humans. These studies help determine how often a drug should be given and if there are important side effects that doctors and patients need to be aware of.
- Phase 2 studies have the primary objective of exploring
the therapeutic effect and to further evaluate safety of a drug in
patients with the disease or condition intended for treatment.
- Phase 3 studies are conducted in larger groups of patients
and are conducted to confirm the safety and efficacy of a drug in
the treating the intended disease. Because Phase 3 studies are
larger, they allow investigators to find and understand less common
side effects of the drug. This is important information for doctors
and patients to know before use in the wider general population.
Phase 3b studies are either studies conducted while a drug is under
review by a regulatory authority or are studies conducted in
patients that do not fall within the proposed or approved drug
- Phase 4 postmarketing studies are conducted
after a drug is approved to gain additional information, including
the drug’s effects across various populations and side effects
associated with long-term use in the drug’s approved
Following approval of a drug or biologic product, the US Food and Drug Administration (FDA) or other regulatory agencies may request and/or require the sponsoring company to conduct further studies that are designed to gather additional information about the product’s safety, effectiveness and/or optimal use. These Postmarketing Commitment (PMC) studies build upon the data that was submitted for approval.
To view our Postmarketing Commitments in the United States (and those of our prior sponsor, Abbott Laboratories), see our PMC Summary Table.
The Postmarketing Commitment Summary Table includes our active PMCs and provides the following information, organized alphabetically by product name:
- Name of Product New Drug Application (NDA)/ Biologics license application (BLA) Number
- Description of Commitment
- Date Commitment
- Projected Completion Date
- Commitment Status
Please note that the status and/or number of our PMCs shown on the FDA website may differ from the information displayed on our PMC Summary Table due to the timing of content review and website updates. The status categories used in the PMC Summary Table are consistent with categories used by the FDA.
Information about our Postmarketing Commitments will be updated twice a year to reflect new commitments as well as the progress we have made in fulfilling our existing PMCs. Once the FDA determines a PMC is fulfilled or should not be completed, or if we terminate a study before completion date, those PMCs will be removed from our PMC Summary Table.
The Postmarketing Commitments listed in the PMC Summary Table include nonclinical (nonhuman), clinical (medical) and epidemiological studies that we have agreed to conduct to gather additional information about the safe and effective use of our approved products. This website does not contain technical chemistry, manufacturing and controls PMCs or PMCs for products for which our company does not hold the US regulatory approval.