FDA Flags Manufacturing Issues at Biologics Facility in India
The U.S. Food and Drug Administration (FDA) has flagged violations at a large manufacturing facility in India, which distributes biologics and drugs in the United States. The FDA issued a Form 483 with seven inspection observations following a recent review of Dr. Reddy’s Laboratories, a biologics manufacturing facility in Bachupally, Hyderabad, India. The agency has […]
FDA Refuses to Review Moderna’s mRNA Influenza Shot License Application
The U.S. Food and Drug Administration (FDA) has declined to accept for review Moderna’s Biologics License Application (BLA) for its mRNA-based seasonal influenza shot, citing concerns about the completeness of the submission. The decision highlights the agency’s commitment to maintaining clear evidentiary standards for approving the licensing of new vaccines.1 On Feb. 3, 2026, the […]
WHO Prequalifies Takeda’s Qdenga Dengue Vaccine
On May 10, 2024, the World Health Organization (WHO) granted prequalification status to the Qdenga (TAK-003) dengue vaccine, developed by Takeda Pharmaceutical Company Ltd. of Tokyo, Japan. The live attenuated virus vaccine is recommended to be given in two doses three months apart to children six to 16 years old living in areas where dengue […]
The Impending U.S. ICD Vaccine Passport and Its Unconstitutionality
The CDC recently codified International Classification of Disease (ICD) codes for COVID-19 vaccine status. ICD codes are extensively used in medical records, medical insurance data and health research to classify precisely disease states as well as injuries from exogenous agents such as accidents, medication and medical device injuries, toxic chemicals, etc. Vaccination status is not […]
Fluzone Quadrivalent Influenza Vaccine Approved by FDA for Elderly
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (BLA) for the Fluzone high-dose quadrivalent influenza vaccine for use by adults 65 years of age and older. Fluzone is manufactured by Sanofi Pasteur, Inc. of France.1 2 The Fluzone high-dose influenza vaccine was approved by the FDA in 2009 as […]
Novartis Manipulated Data in FDA Biologics License Application
On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]