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October 21, 2022

IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations

Docket Number: FDA-2021-D-1140 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
October 21, 2022

Patients More Likely to Call Women Docs and DOs by First Name Patients More Likely to Call Women Docs and DOs by First Name

Most physicians want their patients to call them “Doctor” unless they give them permission to use their first name. When patients don’t ask for permission and […]
October 21, 2022

New Consensus on Managing Nausea and Vomiting in Pregnancy New Consensus on Managing Nausea and Vomiting in Pregnancy

Although the nausea and vomiting associated with pregnancy are usually mild, they are more severe (hyperemesis gravidarum) in around one third of women and require hospitalization […]
October 21, 2022

Contraceptive Use Declines After Breast Cancer Diagnosis Contraceptive Use Declines After Breast Cancer Diagnosis

Contraceptive use declined significantly after treatment for early breast cancer, according to a prospective analysis of nearly 3000 premenopausal women. More specifically, at diagnosis, more than […]
October 21, 2022

Few Transgender Teens Discontinue Hormones in Young Adulthood Few Transgender Teens Discontinue Hormones in Young Adulthood

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as […]
October 21, 2022

Is Hyperbaric Oxygen the Answer for Concussion Treatment in Kids? Is Hyperbaric Oxygen the Answer for Concussion Treatment in Kids?

Hyperbaric oxygen therapy may help resolve symptoms of concussion in children years after they have suffered a brain injury, researchers in Israel have found. As many […]
October 21, 2022

Autochthonous Transmission of Dengue Fever Rising in France Autochthonous Transmission of Dengue Fever Rising in France

As of Sept. 20, 2022, 47 autochthonous cases of dengue fever, spread across five clusters, have been reported in mainland France since July. These figures mark an increase […]
October 21, 2022

FDA issues final guidance about multiple endpoints in clinical trials

Today, FDA issued the Multiple Endpoints in Clinical Trials Final Guidance for Industry. This final guidance provides sponsors and review staff with the Agency’s thinking about […]
October 21, 2022

FDA issues final guidance about multiple endpoints in clinical trials

Today, FDA issued the Multiple Endpoints in Clinical Trials Final Guidance for Industry. This final guidance provides sponsors and review staff with the Agency’s thinking about […]
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