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October 21, 2022

25 Years of Chickenpox Vaccine: 91 Million Cases Prevented 25 Years of Chickenpox Vaccine: 91 Million Cases Prevented

WASHINGTON, DC — In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has […]
October 21, 2022

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

Docket Number: FDA-2022-D-1270 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants who submit abbreviated new drug […]
October 21, 2022

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

Docket Number: FDA-2022-D-1270 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants who submit abbreviated new drug […]
October 21, 2022

Myocarditis After COVID Shot Rare and Mild in Teens Myocarditis After COVID Shot Rare and Mild in Teens

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents — one […]
October 21, 2022

Sexual Healthcare for Disabled Youth: Tough and Getting Tougher Sexual Healthcare for Disabled Youth: Tough and Getting Tougher

The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, helped care for […]
October 21, 2022

New Findings on Rare Mucinous Ovarian Cancer May Change Tx New Findings on Rare Mucinous Ovarian Cancer May Change Tx

The largest study to date of mucinous ovarian cancer (MOC) offers hope for a more personalized treatment approach in patients diagnosed early with this rare form […]
October 21, 2022

The Periodontitis-Diabetes Link Goes Both Ways The Periodontitis-Diabetes Link Goes Both Ways

Researchers published the study covered in this summary on Research Square as a preprint that has not yet been peer-reviewed. Key Takeaways The association between type […]
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

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 […]
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