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Mitigating Risks of Compounded Drugs Through Surveillance: The FDA reviews adverse event and product quality reports, and takes action to mitigate identified risks. We also raise awareness about risks related to human drug compounding.
The U.S. Food and Drug Administration (FDA), with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a workshop, “Accelerating Product Development for Pediatric Systemic Lupus Erythematosus” on July 30-31, 2026. This workshop will examine key similarities and differences between adult and pedia
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed. Learn more.
Quinacrine appears on the FDA 503B list of bulk drug substances that may be used in ccompounded drugs. FDA’s review for the 503B Bulks List determined that there is a clinical need for drug products compounded from quinacrine in the treatment of some patients with cutaneous lupus erythematosus.
Learn what HIV is and how CDER is working to prevent and treat HIV infections
PHILADELPHIA, June 9, 2026— Former American College of Physicians (ACP) President, Sandra A. Fryhofer, MD, MACP, was elected the American Medical Association (AMA) President-Elect at the AMA House of Delegates Annual Meeting in Chicago earlier today. Dr. Fryhofer will be AMA President-Elect 2026 to 2027 and will assume the role of AMA President the following year. “Dr. Fryhofer has been a strong advocate for internal medicine, physicians, and our patients for years,” said Jan K. Carney, MD, MPH, president, ACP. “With her background in public health, her work in vaccine advocacy, and her…
CGMP/Finished Pharmaceuticals/Adulterated
CGMP/Finished Pharmaceuticals/Adulterated
CGMP/Finished Pharmaceuticals/Adulterated
CGMP/Finished Pharmaceuticals/Adulterated
With the CE mark for ear, nose and throat procedures, the advanced surgical navigation platform will be available to more surgeons across the region.
New study results could lead to better insurance coverage of the devices for people who don’t take insulin, a researcher said.
CGMP/OTC Finished Pharmaceuticals/Adulterated
How you use sunscreens, and what other protective measures you take, make a difference in how well you are able to protect yourself and your family from sunburn, skin cancer, early skin aging and other risks of overexposure to the sun.
Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation.
The changes support accuracy across diverse patient populations, skin tones and clinical care settings.
by Luigi Russo, Erika Giacobini, Nicolò Lentini, Tommaso Osti, Maud Kamal, Stefania Boccia, Roberta Pastorino Background Molecular Tumor Boards (MTBs) bring together multidisciplinary experts to translate genomic data into clinical decisions in oncology, however, their overall clinical impact remains unclear. The aim of this systematic review is to assess the clinical impact of MTB-recommended therapies on patients with cancer outcomes. Methods and findings In this systematic review and meta-analysis, we searched PubMed, Embase, Scopus, and CENTRAL up to July 2025. We included studies of any…
by Patrick Staunton, Mohammad Adib Makrooni, Master Chisale, Billy Nyambolo, Joseph Wu, Damien McCarthy, Mark Ledwidge, Yasir Bin Nisar, Chris Watson, Balwani Mbakaya, Cathal Seoighe, Joe Gallagher Background Globally, pneumonia remains the single biggest cause of mortality in children under 5 years of age. This study sought to train and test a prediction model for hospitalisation within 7 days after initial presentation in 2- to 59-month-old Malawian children with WHO-defined pneumonia in primary care and compare its performance to existing risk prediction models. Methods and findings BIOTOPE…
SOC 2, HITRUST, and BAAs should be treated as starting points, not trust signals. They tell you what a vendor claims about its controls. They do not tell you whether those controls are actually working today or whether the evidence behind the attestation was real. The post Healthcare’s Assurance Infrastructure Is Broken. The Compliance Industry Built It That Way appeared first on MedCity News .
The true promise of AI lies not in autonomy of either the clinician or machine, but in a balanced collaboration that bolsters the strengths of each. The post Bridging Movement and Machine Learning: How Clinicians Can Harness AI in Practice appeared first on MedCity News .
It’s not hard to understand why patients turn to social media for GLP-1 guidance. The healthcare system leaves a huge gap between getting a prescription and actually understanding how to use it well. The post GLP-1s Are a $70 Billion Market — So Why Are Patients Still Getting Medical Advice From TikTok Influencers? appeared first on MedCity News .
Information related to FDA’s preparation for the seventh reauthorization of PDUFA.