Arthur A Ciociola

How Drugs are Developed and Approved by the FDA: Current Process and Future Directions

OBJECTIVES:This article provides an overview of FDAs regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future.METHODS:A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical industry R&D productivity and drug development cost estimates.RESULTS:While the drug approval process remains at high risk and spans over multiple years, the FDA drug review and approval process has improved, with the median approval time for new molecular drugs been reduced from 19 months to 10 months. The overall cost to development of a drug remains quite high and has been estimated to range from

How the FDA Manages Drug Safety With Black Box Warnings, Use Restrictions, and Drug Removal, With Attention to Gastrointestinal Medications

868M to

Direct neutralization of esophageal acid by antacid in meal-induced heartburn

1,241M USD. Several new laws have been enacted, including the FDA Safety and Innovation Act (FDASIA) of 2013, which is designed to improve the drug approval process and enhance access to new medicines.CONCLUSIONS:The FDAs improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drug-related harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.

Integrated acidity: a novel technique demonstrating synergy between low dose ranitidine and antacid for acid reduction and relief of meal-induced heartburn

How the FDA Manages Drug Safety With Black Box Warnings, Use Restrictions, and Drug Removal, With Attention to Gastrointestinal Medications

Integrated acidity and heartburn severity determine timing of self-medication in postprandial heartburn

Background: Antacids are thought to relieve heartburn by neutralizing gastric acid. Previously, we described antacid efficacy in heartburn as due to direct reduction of intraluminal esophageal acid (Gastroenterology 1999;116:A292).

Measurement of meal-stimulated gastric acid secretion by in vivo gastric autotitration

Integrated acidity: a novel technique demonstrating synergy between low dose ranitidine and antacid for acid reduction and relief of meal-induced heartburn

In GERD patients taking a morning dose of omeprazole, bedtime low-dose ranitidine is equivalent to bedtime omeprazole for inhibition of nocturnal gastric acidity

Integrated acidity and heartburn severity determine timing of self-medication in postprandial heartburn