Date Issued Type Title Statements 3/19/2024 Proposed Rule Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B […]
By: Cassandra L. Taylor, public health advisor, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Schuyler Pruyn, project manager, Office of […]
The US Food and Drug Administration (FDA) has approved aprocitentan (Tryvio) to lower blood pressure, in combination with other antihypertensive agents, in adults with treatment-resistant hypertension. […]
TOPLINE: Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a […]
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 […]
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