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January 17, 2023

BPD Tied to Longer Time to Depression Remission BPD Tied to Longer Time to Depression Remission

Patients with borderline personality disorder and major depressive episodes had a longer time to depression remission than patients with major depressive disorder or bipolar disorder who […]
January 17, 2023

Belimumab for Pregnant Women With Lupus: B-Cell Concerns Remain Belimumab for Pregnant Women With Lupus: B-Cell Concerns Remain

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the […]
January 17, 2023

HRT May Prevent Alzheimer’s in High-Risk Women HRT May Prevent Alzheimer’s in High-Risk Women

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests. Results from […]
January 17, 2023

FDA Rationale for Piperacillin-Tazobactam Breakpoints for Enterobacterales

FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Enterobacterales” (MR14, February 2022), submitted by the Clinical and Laboratory Standards Institute (CLSI) […]
January 17, 2023

FDA Rationale for Polymyxin Breakpoints for Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.

FDA has completed their review of the rationale document titled, “Polymyxin Breakpoints for Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp. – CLSI Rationale Document MR01-Ed2, April 2020,” […]
January 17, 2023

Optum Infusion Services 308 LLC – 647842 – 12/13/2022

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name William J. Kottmer, PharmD Recipient Title General Manager Optum Infusion Services 308 LLC 2555 West […]
January 17, 2023

HIS Enterprise Inc dba Adam’s Secret USA, LLC – 646494 – 01/10/2023

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER January 10, 2023 PO Box 281Palisades […]
January 17, 2023

Clinical Investigator Administrative Actions – Disqualification

Docket Number: FDA-2010-D-0265 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical […]
January 16, 2023

Metformin Monotherapy Not Always Best Start in Type 2 Diabetes Metformin Monotherapy Not Always Best Start in Type 2 Diabetes

Metformin failure in people with type 2 diabetes is very common, particularly among those with high A1c levels at the time of diagnosis, new findings suggest. […]
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