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Will the Agency Relax Existing Industry-Opposed Restrictions?
The Food and Drug Administration issued draft guidances in January that tackled health care economic information and product labeling. Do these publications indicate a potential shift in on- and off-label policies for drugs and devices?
The authors review the historical use of medicinal cannabis and discuss the agent’s pharmacology and pharmacokinetics, select evidence on medicinal uses, and the implications of evolving regulations on the acute care hospital setting.
An Evaluation of Selected Indications and Appropriateness of Ampicillin/Sulbactam, an Unrestricted Antimicrobial, at a Single Center
An antimicrobial stewardship program team presents their findings after reviewing the usage of ampicillin/sulbactam and assessing prescribing habits and accuracy at a 775-bed nonprofit research and teaching hospital.
Interleukin-5 (IL-5) is known to play a major role in the growth, differentiation, recruitment, and activation of eosinophils. The authors review the efficacy and safety of two IL-5–targeting agents used in the treatment of eosinophilic asthma.
We present sessions on establishing key clinical trial outcomes in psoriatic arthritis and on delaying the radiographic progression of ankylosing spondylitis.
Practice changes cause the mislabeling of batched drugs
New FDA and GAO reports highlight compounding issues
New Drugs/Drug News
Approvals, new indications, regulatory activities, and more
Insulin degludec/liraglutide (Xultophy 100/3.6) for type-2 diabetes; rucaparib (Rubraca) for the treatment of deleterious BRCA mutation-associated ovarian cancer; and nusinersen (Spinraza) for the treatment of spinal muscular atrophy
Rolapitant (Varubi) for the prevention of chemotherapy-induced nausea and vomiting