Drug recall: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive,…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
The latest headlines across every section, pulled from official and open-access sources.
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. — Thea Pharma, Inc. · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. — Alcon Research LLC · Class II · Ongoing
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. — Hikma Pharmaceuticals USA INC · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Lack of Assurance of Sterility — SCOPE HEALTH · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Failed PH Specifications — Water-Jel Technologies, LLC · Class III · Ongoing
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. — Alcon Research LLC · Class II · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
Labeling: Missing Label — American Regent, Inc. · Class III · Ongoing
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.
by Yanshang Wang, Chang Cai, Zhenyu Shi, Qian Gao, Alex Bottle, Mansour Taghavi Azar Sharabiani, Joshua Stott, Benedict Hayhoe, Ping He Background The prevalence of physical, psychological, and cognitive multimorbidity is characterised by marked socioeconomic status (SES) inequalities. However, the relationships between multimorbidity patterns—particularly those involving cognitive conditions—and healthcare utilisation, as well as the role of health insurance, remain poorly understood. This study aims to explore healthcare-seeking behaviour among individuals with multimorbidity and assess…
Dr. Centor discusses advancing clinical mastery as a strategy to revitalize primary care practice with Dr. Richard Kravitz.
Hepatitis B virus (HBV) infection affects around 254 million people worldwide and causes more than 1 million deaths annually. Author Anna Lok, MD, from the University of Michigan discusses HBV transmission, screening, and treatment with JAMA Associate Editor Beverly Forsyth, MD. Related Content: Hepatitis B Hepatitis B Virus Treatment Gaps in the US Tenofovir and Hepatitis B Virus Transmission During Pregnancy US Newborn Hepatitis B Virus Vaccination Rates
NCI Director Dr. Anthony Letai shares his reflections on this year’s AACR Annual Meeting, including science that stood out and NCI’s leading priorities.
NCI Director Dr. Anthony Letai shares his reflections on this year’s AACR Annual Meeting, including science that stood out and NCI’s leading priorities.
Ten years ago, the UN Security Council unanimously adopted Resolution 2286 on health care in armed conflicts. The situation is even worse compared to 10 years ago. Today, we mark not an achievement – we mark a failure. As violence affecting medical facilities, transport and personnel continues unabated, the harm this resolution sought to prevent has not diminished. It has continued and, in many contexts, intensified. As the heads of the International Committee of the Red Cross (ICRC), the World Health Organization (WHO), and Médecins Sans Frontières (MSF), we join others in the international…
Tens of thousands of patients could benefit from a ‘rapid’ new immunotherapy jab on the NHS for over a dozen different cancers, which can be given in just 60 seconds. The NHS is rolling out a new injectable form of pembrolizumab (Keytruda) which can slash the time the treatment takes by up to 90%, to […]
Member States of the World Health Organization (WHO) have progressed work on the Pathogen Access and Benefit Sharing (PABS) annex, a key part of the WHO Pandemic Agreement, and today agreed additional time was needed to finalize the framework for ensuring a better, more equitable, response to future pandemics. Countries today ended the resumed session of the sixth meeting of the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement in Geneva, focused on the PABS system. The outcome of this work will be presented to the Seventy-ninth World Health Assembly (WHA) later this month…
FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.