Fast-track drug designation of safe regimens represents an emerging method of development and approval of new medications targeting debilitating diseases including inflammatory bowel diseases (IBD). The goal of accelerated drug approval pathways is to shorten the time between application and approval of therapies that treat diseases with significant morbidity and mortality. Recently, fast-track drug approval approaches were supported by data deriving from central reading of images, a method of clinical data interpretation that has significantly benefited patients with gastrointestinal disorders. Biological agents and other emerging therapies in IBD represent “game-changing” or “treat-to-target” drugs and have satisfied quite successfully some of the patients’ unmet needs. The development of biosimilars is an area where the Federal Drug Administration and the European Agency for Evaluation of Medicinal Products seem to have different approval processes. Biosimilars, including those for IBD, promise cost reductions and wide access to biologic therapies by patients, advantages similar to those already offered by generic drugs. Given the rapid development of IBD drugs and patients’ needs, a consensus among the academic community, clinicians, researchers, sponsors, patients and regulatory authorities is required to standardize better the IBD trials and create a productive environment for fast-track approval of any “changing-game” IBD drug.

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Pulmonary involvement seems to be a more frequent extraintestinal manifestation of IBD than thus far supposed. In IBD, the respiratory involvement may include a wide range of pathologies. The patients with IBD are in high risk of infections. The drugs used in the treatment of IBD (sulfasalazine, mesalamine, infliximab, and methotrexate) can induce pulmonary diseases as a side effect.Pulmonary function tests and high resolution CT are useful for detecting subclinical or clinical pulmonary involvement in IBD patients. Pulmonary function tests (PFT) and high-resolution CT (HRCT) showed abnormality in about one-quarter of patients with IBD. Corticosteroids, both systemic and aerosolized, are the main therapeutical approach, while antibiotics must also be administered in infections. Early identification is important as early treatment may improve long-term outcomes in these patients.

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