Idiopathic pulmonary fibrosis (IPF) is the most common of the idiopathic interstitial pneumonias. Despite multiple recent clinical trials, there is no strong evidence supporting a survival advantage for any agent in the management of patients with IPF. The limited effectiveness of current treatment regimes has led to a search for novel therapies including antifibrotic strategies. This article reviews the evidence supporting the treatments currently used in the management of IPF

Introduction: Patients with either acromegaly or neuroendocrine tumors (NET) can be treated with somatostatin analogs to relieve symptoms and improve disease control. However, there is an absence of large clinical trials specifically designed to document the safety when increases in somatostatin analog dosing are needed in patients who do not achieve their treatment goals. To fully explore and communicate any potential risks, we conducted a literature review and present a summary of the studies documenting the safety and tolerability of dose optimization with somatostatin analogs in patients with acromegaly and NET. Methods: A literature search was undertaken to find clinical studies specifically reporting the effects of dose titration using the depot formulations of the somatostatin analogs, octreotide long-acting repeatable (LAR) or lanreotide, in patients with acromegaly and NET. Results: Publications that described the treatment and management of patients with acromegaly and NET were reviewed. The rationale for dose optimization, including high-dose treatment in patients who are inadequately controlled on conventional doses and the safety and tolerability of somatostatin analogs, is discussed. Conclusion: A review of published clinical studies demonstrates that dose optimization provides additional biochemical control in patients with acromegaly and NET who are inadequately controlled with conventional starting doses of octreotide LAR and lanreotide ATG. The benefits of dose optimization include improved efficacy without a significant change in the recorded adverse events and the tolerability of the treatment. Therefore, patient response to treatment should be routinely monitored and their somatostatin analog dose increased or decreased thereafter according to their individual response.

Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA). The Pure Food and Drug Act of 1906 was the first comprehensive federal legislation covering drug regulation. Intervening legislation, such as the Federal Food, Drug, and Cosmetic Act of 1938 and Kefauver-Harris Amendments in 1962, was later instituted. In June 2006, a century after the development of the FDA as an enforcement body, an initiative was undertaken to remove unapproved drugs from the marketplace. The Marketed Unapproved Drugs – Compliance Policy Guide outlines enforcement policies aimed at efficiently and rationally bringing all unapproved and illegally marketed drugs into the approval process, or discontinuing their manufacture, distribution, and sale. The FDA has been actively pursuing control of unapproved drugs in recent years, with an approach concentrating on drug safety to ensure optimal public health and consumer protection.