10.20.2020

Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020

Coronavirus (COVID-19) Update: Daily Roundup
10.20.2020

FDALabel: Full-Text Search of Drug Labeling

FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 100,000 drug labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.
10.20.2020

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation.
10.20.2020

Compounding Activities | COVID-19

Providing guidance on compounded drugs
10.20.2020

FDA Voices

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.
10.20.2020

FDA Voices on Medical Products

FDA Voices on Medical Products
10.20.2020

FDA updates on hand sanitizers consumers should not use

FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol
10.20.2020

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid

FDA warns that NSAID use at 20 weeks or later in pregnancy may cause serious kidney problems in an unborn baby, leading to low amniotic fluid levels. Do not take NSAIDs unless advised to do so by your health care professional.
10.20.2020

Drug Safety and Risk Management Advisory Committee Roster

This page contains the DSARM roster, which lists the current members and the current number of vacancies for the committee.
10.20.2020

Consumer Updates

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.