Alcohol-Based Hand Sanitizers From Mexico Are On Import Alert
On January 26, the U.S. Food and Drug Administration (FDA) announced about continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the…
FDA
FDA Approves Cabenuva: First ER, Injectable Drug Regimen for Adults With HIV
On January 2, the U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human…
FDA’s Artificial Intelligence/Machine Learning Software
On January 12, the U.S. Food and Drug Administration released the first FDA’s Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan….
FDA’s Alert Regarding SARS-CoV-2 Viral Mutation
The U.S. Food and Drug Administration (FDA) released a warning message to clinical laboratory staff and health care providers that the FDA is monitoring the…
Moderna’s COVID-19 Vaccine Supply Update
Moderna, Inc., provided a supply update for the Moderna’s COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021….
FDA On COVID-19 Vaccines Dosing Schedules
On January 4th, commissioner of food and drugs – Food and Drug Administration Stephen M. Hahn M.D., and director – center for biologics evaluation and…
FDA On The Age Of Individualized Medicine
Recently, it was announced about new steps to provide clarity on developing new drug products in the age of individualized medicine by U.S. Food and…
Generic Drug Glucagon Approved
On December 28, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit,…
FDA Authorizes Marketing Of The EndoRotor System
On December 23, the U.S. Food and Drug Administration (FDA) authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue…
FDA Approval Of Klisyri (tirbanibulin)
Recently. Almirall, S.A., a global biopharmaceutical company focused on skin health, announced that Klisyri (tirb anibulin) has been approved by the U.S. Food and Drug…