Sentence examples for fda rejected from inspiring English sources
The FDA rejected Wyeth's proposal.
Consequently, the FDA rejected the Plaintiffs' health claim as misleading and not curable by disclaimer.
The FDA rejected that request, citing a lack of data on how the drug effected young teenagers.
The FDA rejected Vivus's Qnexa in 2010 over concerns for the safety of pregnant women and the quickening of patients' heart rates.
After advisory panels voted not to recommend two experimental weight-loss drugs, Arena's Lorcaserin and Vivus's Qnexa, the FDA rejected both drugs in late October, while another obesity drug, Orexigen's Contrave, was endorsed by an FDA panel in December.
The FDA rejected the application because of safety issues exposed in clinical trials; the agency then changed the rules for the trials and three years later Opana was approved.
More puzzling still was Northfield's decision to apply for approval in August 2001, three years after the trial ended, touting in a press release that its clinical data "provides the substantial evidence of safety and efficacy required by the FDA". Unsurprisingly, the agency rejected Northfield's application and demanded more clinical trials.
Indeed, just last month, Obama's HHS rejected an FDA-approved protocol that would have researched whether marijuana can reduce PTSD among combat veterans.
All of these studies were rejected by the U.S. FDA as not adequate for making regulatory decisions about the safety of BPA.
In the process, that court narrowed the scope of so-called "FDA exemption" and stunned the biotech community.The Supreme Court today rejected such a narrow view, saying that research even untied to a specific drug approval effort could be eligible for the FDA exemption.
