Tag: FDA

LIVE NOW: FDA, HHS Advisory Board Meeting on Nonprescription Birth Control Pill (Day 2)

The Food and Drug Administration (FDA) and Department of Health and Human Services hold a public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee from 9:30 a.m. to 1:30 p.m. ET on May 10. The committees discuss supplemental new drug application (sNDA) 017031/S-041, for OPILL…


FDA, HHS Advisory Board Meeting on Nonprescription Birth Control Pill (Day 2)

The Food and Drug Administration (FDA) and Department of Health and Human Services hold a public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee from 9:30 a.m. to 1:30 p.m. ET on May 10. The committees discuss supplemental new drug application (sNDA) 017031/S-041, for OPILL…


LIVE 9:30 AM ET: FDA, HHS Advisory Board Meeting on a Nonprescription Birth Control Pill

The Food and Drug Administration (FDA) and Department of Health and Human Services hold a public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee from 9:30 a.m. to 5:30 p.m. ET on May 9. The committees discuss supplemental new drug application (sNDA) 017031/S-041, for OPILL…


LIVE NOW: FDA, HHS Advisory Board Meeting on a Nonprescription Birth Control Pill

The Food and Drug Administration (FDA) and Department of Health and Human Services hold a public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee from 9:30 a.m. to 5:30 p.m. ET on May 9. The committees discuss supplemental new drug application (sNDA) 017031/S-041, for OPILL…


FDA Overhaul Needed for New Vaccines and mRNA Therapies

The pandemic has ended, but the introduction of the COVID-19 vaccines which use mRNA technology, signifies the start of a new era in modern medicine. The lagging regulatory framework which the FDA cobbled together specifically for mRNA vaccine approval has set the stage for adverse events related to genetic therapies using this new technology. In…


FDA Issues Emergency Warning for 500,000 COVID Tests

The FDA issued a warning to consumers Thursday to stop using a certain COVID-19 at-home test due to the potential for a bacterial contamination in the product’s liquid solution. In a bulletin, the FDA said that consumers and medical care providers to stop using and toss out certain lots of the testing kit made by…


FDA Panel Backs Restricted Use of AstraZeneca’s Prostate Cancer Drug

A panel of U.S. Food and Drug Administration (FDA) advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc.’s experimental treatment, jointly developed with Merck & Co., for a type of prostate cancer. The FDA panel voted 11–1 with one abstention, in favor of Lynparza, in combination with other medications—abiraterone and prednisone…


FDA Reports Shortage of Version of Penicillin Used as Standard Syphilis Treatment

The U.S. Food and Drug Administration (FDA) has reported a shortage of the injectable version of penicillin, citing increased demand for the antibiotic. In a notice on April 26, the agency said there are shortages of Pfizer’s Bicillin L-A in both regular and pediatric versions. It said the shortage may persist until around the last…


FDA Announces Company-Wide Recall of All Drugs for People and Pets

A drug company is recalling all of its drugs for people and pets because it can’t assure the quality, according to a Food and Drug Administration (FDA) announcement on Wednesday. Akorn Operating Company LLC said that it filed for Chapter 7 bankruptcy earlier this year and as a result, “ceased and shutdown all operations and terminated…


FDA Issues Safety Concerns Over Amniotic Fluid Eyedrops

The U.S. Food and Drug Administration (FDA) recently issued an alert to patients and health care practitioners about safety concerns surrounding amniotic fluid eye drops that have been marketed and distributed to treat or mitigate dry eye disease and similar conditions. The FDA noted that manufacturers of the amniotic fluid eye-drop products of the brands…