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Utilization of Treatment for Chlamydia and Gonorrhea in the Primary Care Setting Using the American Family Cohort [Infectious diseases (not respiratory tract)]

Annals of Family Medicine

Since untreated cases can have severe health consequences, non-adherence to the Centers for Disease Control and Prevention Sexually Transmitted Disease Treatment guidelines (CDC) remains a concern. Study Design and Analysis: A retrospective cohort from 2018-2022. treatment rates, respectively.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

Clinic 52
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FDA Creates a New Advisory Committee for Genetic Metabolic Diseases – Could This Be an Opportunity to Support Rare Disease Product Development More Broadly?

FDA Law

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. However, the challenges faced by these stakeholders are not isolated to products overseen by DRDMG alone.

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District Court Interprets EKRA

FDA Law

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. These lab tests are performed for physicians, substance abuse treatment centers and other types of organizations.

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A prophylactic treatment for hemophilia that you should know about

PEMBlog

Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors.