Thirty preapproval studies supported the 24 indications. The median number of participants enrolled in preapproval studies was 132. Fifty percent of the 38 required confirmatory studies were completed at a minimum 3 years of follow-up.
Among the areas likely to benefit from increased funding are treatment centers, with the White House panel recommending rules be waived so that Medicaid recipients can get treatment for their addictions.
"No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require," said FDA Commissioner Scott Gottlieb, MD.
The Agency's proposed rule is to ensure that regular use of these products does not pose unknown safety and efficacy concerns.
Steps should be taken to combat the impending physician shortage of between 61,700 and 94,700 doctors that the U.S. is expected to face over the next decade.
The American Medical Association (AMA) announced the adoption of a new policy discouraging the nonmedical use of prescription drugs for cognitive enhancement in healthy individuals.
A policy introducing nutrition standards for competitive beverages can improve the nutritional quality of beverages sold in schools.
Despite the well-established data demonstrating that pediatric vaccines are life-saving, safe, and effective, significant obstacles remain to their implementation, on both patient and provider levels.
Many lung and esophageal cancer survivors have positron emission tomography (PET) imaging scans as part of ongoing monitoring, but many of those scans may be unnecessary, according to a study published online in the Journal of the National Cancer Institute.
Physicians recently met in Seattle to discuss the difficulties and benefits associated with electronic health records (EHRs) in a third town hall meeting on the subject, according to a report published by the American Medical Association.
A case before the Supreme Court is potentially threatening patient confidentiality, according to the American Medical Association (AMA).
Results from one of the largest studies ever conducted to understand obesity treatment coverage show that 3 out of 4 consumers report they are not covered for necessary, evidence-based obesity treatment services. Findings from the study were presented at ObesityWeek 2015.