Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped between product complexity and time to approval by US Food Drug Administration (FDA). Moreover, argue that association contingent on types strategic alliances (i.e., R&D alliance, Marketing alliance) focal those help FDA pharmaceutical companies a...

One of the critical path initiatives of the Food and Drug Administration (FDA) is to accelerate the development and availability of a safe and effective artificial pancreas for the treatment of diabetes mellitus. The FDA has established a multidisciplinary group of scientists and clinicians, in partnership with the National Institutes of Health (NIH), to address the clinical, scientific and reg...

At the request of the Food and Drug Administration (FDA) and with its funding, the Panel on the Handling of Missing Data in Clinical Trials was created by the National Research Council's Committee on National Statistics. This panel recently published a report(1) with recommendations that will be of use not only to the FDA but also to the entire clinical trial community so that the latter can ta...

Administration of parenteral iron and mortality among hemodialysis patients. J Am Soc Nephrol 2004;15:1623–32. 24 Bokemeyer C, Aapro MS, Courdi A et al; European Organisation for Research and Treatment of Cancer (EORTC). Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Review. Eur J Cancer 2007;43:258–70. 25 Rizzo J...

The Office of combination products OCP, an agency to regulate the under US Food and Drug Administration (FDA) has released final guidance on for its approval which is named “Principles Premarket Pathways Combination Drugs,” provides FDA’s current strategies into market. guideline, comparable draft notification issued in February 2019, emphasizes specifies five particular instances those techniq...

As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed Bracco Diagnostics Inc.’s (Bracco) website at http://www.impactcin.com (IMPACT website) for its drug product, Isovue (iopamidol injection) (Isovue). The website contains false and unsubstantiated claims related to...

A total of 292 field investigative reports of drug residues in food animals for 1983 to 1988 were analyzed. The investigations had been conducted by the Food and Drug Administration (FDA) and the Virginia State Veterinarian's Office, in cooperation with the Center for Veterinary Medicine of the FDA, to trace residues reported by the USDA Food Safety and Inspection Service to the source of the a...

Funding/Support: The survey, part of an ongoing Harvard School of Public Health series focused on the public’s response to public health emergencies, was funded under a cooperative agreement with the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Public Health Information Coalition (NPHIC). Disclaimer: The contents of this article are ...

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a professional sales aid (AT39696) for Strattera (atomoxetine HCl) (Strattera) submitted by Eli Lilly and Company (Eli Lilly) under cover of Form FDA 2253. This piece is false or misleading because it broadens the indication for and overstates the efficacy of Strat...

In 1994, the Food and Drug Administration Office of Women's Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women's health. Within its first year, the FDA-OWH established a science program for women's health research, promoting the development of sound policy and regulation. In a little over a decade, the program has provided approximat...