In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only […]
TOPLINE: Inhibitory repetitive transcranial magnetic stimulation (rTMS) of the supplementary motor area (SMA) was associated with significant improvement in psychomotor slowing in psychosis — a condition […]
In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model […]
We evaluated three categories of drug products for this proposed rule. We would place all three of these categories of drug products on the Demonstrable Difficulties […]
Submit Comments by 06/20/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
TOPLINE: The addition of supervised exercise to obesity pharmacotherapy has shown greater potential for maintaining weight loss and improving body composition after treatment termination than pharmacotherapy […]
Among adolescents with moderate to severe obesity, a nutritionally balanced, very low-calorie diet with the monitoring of a dietician shows high adherence and safety, with significant […]
For early-stage cervical cancer, non-radical surgery (simple hysterectomy or cone biopsy plus pelvic lymphadenectomy) appears safe with no lasting negative impact on quality of life, according […]
TOPLINE: Sodium-glucose cotransporter 2 inhibitor (SGLT2i)-associated diabetes ketoacidosis (DKA) in people with type 2 diabetes (T2D) is associated with lower degrees of hyperglycemia over the first […]
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