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News

New labeling on TMP-SMX products warns of acute respiratory failure

from the Food and Drug Administration's Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health, Division of Anti-Infectives, and Office of Surveillance and Epidemiology
Published: July 01, 2021
TOPICS: Pharmacology
Abstract
The warnings come after a case series published in Pediatrics described severe acute respiratory failure related to TMP-SMX treatment in five previously healthy adolescents, four of whom were treated for acne vulgaris.
View News titled, New labeling on TMP-SMX products warns of acute respiratory failure
News

FDA encourages culture change for clinical trial enrollment of pregnant and lactating women

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Office of Women’s Health, and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Division of Urology, Obstetrics, and Gynecology
Published: June 01, 2021
TOPICS: Breastfeeding, Gynecology, Maternal and Fetal Medicine, Obstetrics, Urology
Abstract
While society is justifiably concerned about potential harms of clinical trial participation to a pregnant or lactating woman, excluding these individuals from research may do more harm by leaving gaps in knowledge.
View News titled, FDA encourages culture change for clinical trial enrollment of pregnant and lactating women
News

FDA adds prevention of oropharyngeal cancer to HPV vaccine’s indication

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Center for Biologics and Research
Published: May 01, 2021
TOPICS: Adolescent Health/Medicine, Cancer/Neoplastic, Head and Neck Injuries, Vaccine/Immunization
Abstract
The expanded indication broadens the rationale for use to prevent HPV-related cancers in both sexes and includes individuals ages 9 through 45 years.
View News titled, FDA adds prevention of oropharyngeal cancer to HPV vaccine’s indication
News

2 potential biomarkers for ASD clear first step in FDA drug development tool qualification process

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Division of Psychiatry
Published: April 01, 2021
TOPICS: Autism/ASD, Psychiatry/Psychology, Public Health
Abstract
The FDA accepted letters of intent for two proposed biomarkers for autism spectrum disorder from the Foundation for the National Institutes of Health Autism Biomarkers Consortium for Clinical Trials.
View News titled, 2 potential biomarkers for ASD clear first step in FDA drug development tool qualification process
News

FDA committed to advancing minority health

from the Food and Drug Administration's Office of Pediatric Therapeutics, Office of Minority Health and Health Equity and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: March 01, 2021
TOPICS: Environmental Health, Infectious Diseases, Public Health, Social Media, Diversity, equity and inclusion
Abstract
The Food and Drug Administration (FDA) continues to work to eliminate health disparities among diverse racial and ethnic populations.
View News titled, FDA committed to advancing minority health
News

EUAs address medical device needs of pediatric patients during pandemic

from the Food and Drug Administration’s Center for Devices and Radiological Health, Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: January 19, 2021
TOPICS: Infectious Diseases, Public Health, COVID-19
Abstract
The FDA has received emergency use authorization requests for COVID-related medical devices, including infusion pump systems, continuous positive airway pressure machines, airway clearance devices and anesthesia gas machines.
View News titled, EUAs address medical device needs of pediatric patients during pandemic
News

First FDA-approved treatment for COVID-19 includes use in adolescents

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Division of Antivirals
Published: January 01, 2021
TOPICS: Infectious Diseases, Pharmacology, COVID-19
Abstract
The Food and Drug Administration (FDA) has approved the antiviral Veklury (remdesivir) for treatment of COVID-19 requiring hospitalization in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms (kg).
View News titled, First FDA-approved treatment for COVID-19 includes use in adolescents
News

Web tool supports anticipatory guidance for environmental health

from the AAP Division of Pediatric Population Health
Published: December 01, 2020
TOPICS: Environmental Health
Abstract
The free tool includes evidence-based overviews of health hazards related to air, water, food and consumer products.
View News titled, Web tool supports anticipatory guidance for environmental health
News

FDA approvals in 2020 represent many firsts for children

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: December 01, 2020
TOPICS: Pharmacology
Abstract
Ebola treatment, an automated insulin device and two advanced therapeutics for pediatric rheumatologic conditions are among drugs approved for children.
View News titled, FDA approvals in 2020 represent many firsts for children
News

FDA engages patient communities through listening session initiative

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Patient Affairs Staff
Published: November 01, 2020
Abstract
Listening sessions give participants an opportunity to share their experiences living with a disease, insights into risk tolerance and preferences related to clinical trial participation.
View News titled, FDA engages patient communities through listening session initiative
News

Pediatric information added to labeling for 80 drugs, vaccines, blood products

from the Food and Drug Administration’s Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, Division of Pediatric & Maternal Health and the Center for Biologics Evaluation and Research
Published: October 01, 2020
Abstract
The Food and Drug Administration approved new pediatric-friendly dosage forms for products that treat chronic hepatitis C virus infection, stable symptomatic heart failure due to dilated cardiomyopathy and severe hypoglycemia.
View News titled, Pediatric information added to labeling for 80 drugs, vaccines, blood products
News

FDA addresses drug shortages during COVID-19 pandemic

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Drug Shortage Staff
Published: August 21, 2020
TOPICS: Infectious Diseases, Pharmacology, COVID-19
Abstract
Communication with manufacturers, health care professionals and the public is an essential component of the FDA’s efforts to prevent and mitigate drug shortages.
View News titled, FDA addresses drug shortages during COVID-19 pandemic
News

FDA partners with global agencies on development of COVID-19 therapeutics for children

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: July 28, 2020
TOPICS: Infectious Diseases, Pharmacology, Therapeutics, COVID-19
Abstract
Partnerships help ensure that children’s therapeutic needs are addressed without exposing pediatric patients to unnecessary clinical trials.
View News titled, FDA partners with global agencies on development of COVID-19 therapeutics for children
News

FDA considers parent preferences, children’s experience in approving novel myringotomy, tube placement device

from the Food and Drug Administration’s Center for Devices and Radiologic Health, Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: July 01, 2020
Abstract
Otolaryngologists can use the device in the outpatient setting without general anesthesia.
View News titled, FDA considers parent preferences, children’s experience in approving novel myringotomy, tube placement device
News

FDA highlights imperative to obtain evidence through pediatric clinical trials

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: June 01, 2020
Abstract
Delays in pediatric trials can result in prolonged off-label use of products in children without adequate information about dosing, safety and efficacy in pediatric patients.
View News titled, FDA highlights imperative to obtain evidence through pediatric clinical trials
News

How FDA is responding to COVID-19 pandemic

from the Food and Drug Administration's Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Office of Pediatric Therapeutics
Published: April 28, 2020
TOPICS: Infectious Diseases, Public Health, COVID-19
Abstract
The Food and Drug Administration is facilitating efforts to diagnose, treat and prevent the disease, and surveilling medical product supply chains for shortages or disruptions.
View News titled, How FDA is responding to COVID-19 pandemic
News

Drug labels include information on use in pediatric patients

the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: April 01, 2020
TOPICS: Advocacy, Child Care, Community Health Services, Community Pediatrics, Complementary & Integrative Medicine, Health Information Technology, Hospital Medicine, Legislation, Medical Education, Medical Technology and Advancement, Patient Education/Patient Safety/Public Education, Pharmacology
Abstract
The Physician Labeling Rule outlines the content and format of prescribing information for all new prescription drugs and biologics (and supplemental applications) approved on or after June 30, 2001.
View News titled, Drug labels include information on use in pediatric patients
News

Dr. Sachs retires from FDA, leaving mark on pediatric drug development

from the Food and Drug Administration's Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Office of Pediatric Therapeutics
Published: March 10, 2020
Abstract
Throughout her career at the FDA, Hari C. Sachs, M.D., FAAP, was involved in adding pediatric labeling information to hundreds of drugs and biological products as well as in efforts to improve labeling for drugs used during lactation.
View News titled, Dr. Sachs retires from FDA, leaving mark on pediatric drug development
News

What criteria must drugs meet to be sold over the counter?

from the Food and Drug Administration's Center for Drug Evaluation and Research, Division of Nonprescription Drug Products, Division of Pediatric and Maternal Health and Office of Pediatric Therapeutics
Published: February 04, 2020
TOPICS: Pharmacology
Abstract
Drug products can be marketed without a prescription (i.e., nonprescription) or over-the-counter (OTC) if the FDA determines they are safe and effective for use by a consumer without supervision by a licensed health care professional.
View News titled, What criteria must drugs meet to be sold over the counter?
News

FDA approves first drug for pediatric patients with systemic lupus erythematosus

from the Food and Drug Administration's Center for Drug Evaluation and Research, Division of Pulmonary, Allergy and Rheumatology Products, Division of Biometrics II, Division of Pediatric and Maternal Health and Office of Pediatric Therapeutics
Published: December 27, 2019
TOPICS: Pharmacology, Rheumatology/Musculoskeletal Disorders
Abstract
Intravenous (IV) belimumab was approved for children ages 5 years to 17 years with active, seropositive SLE receiving standard care.
View News titled, FDA approves first drug for pediatric patients with systemic lupus erythematosus