October 24, 2024
Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: *Questions have existed among the field districts regarding the existence and extent of their authority to […]
October 24, 2024
Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: FDA occasionally receives requests for microbiological cultures isolated from samples analyzed by FDA. Requests for other […]
October 24, 2024
Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: Section 305 of the Act states: “Before any violation of this Act is reported by the […]
October 24, 2024
Issued by: Guidance Issuing Office Office of Regulatory Affairs BACKGROUND: Potential criminal cases are frequently preceded by an opportunity for proposed defendants to present their views […]
October 24, 2024
The incidence of lung cancer in never-smokers (LCINS) is increasing, and experts think climate change may be driving this. LCINS differs histologically and epidemiologically from smoking-related […]
October 24, 2024
A new study provides real-world evidence to support the potential repurposing of glucagon-like peptide 1 receptor agonists (GLP-1 RAs), used to treat type 2 diabetes and […]
October 24, 2024
NEW YORK — In a three-way debate on whether to prioritize chimeric antigen receptor (CAR) T-cell therapy, bispecific antibodies (BsAbs), or one of the novel oral […]
October 24, 2024
NEW YORK — In the wake of details about the molecular pathophysiology of Waldenström macroglobulinemia (WM), an expert gave an update on current and expanding options […]
October 24, 2024
TOPLINE: Increases in prescriptions for both glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter 2 (SGLT2) inhibitors were observed in patients with type 1 […]