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Regulatory Intelligence & Drug Approvals4 days agoFDA approves first treatment for children aged 4-11 years with APDS, a rare genetic disorder of the immune system
FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome in children 4-11 years who weigh at least 27 kg....
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Regulatory Intelligence & Drug Approvals5 days agoTips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. The FDA continues to...
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Regulatory Intelligence & Drug Approvals5 days agoShould You Put Sunscreen on Infants? Not Usually
Your infant’s sensitive skin is vulnerable to serious burns. But sunscreen isn’t the answer. Infants are at greater risk than adults of sunscreen side effects, such...
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Regulatory Intelligence & Drug Approvals5 days agoFDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of...
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Regulatory Intelligence & Drug Approvals5 days agoDrug Compliance Programs
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.
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Regulatory Intelligence & Drug Approvals5 days agoJobs in Oncology/Hematology
FDA's Office of Hematology Oncology Products is recruiting Medical Oncologists to serve in the dynamic, highly challenging, and innovative atmosphere of oncology drug development and research.
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Regulatory Intelligence & Drug Approvals5 days agoQuestions and Answers: FDA’s regulatory actions on over-the-counter sunscreen
The following questions and answers provide more information on FDA’s regulatory actions on over-the-counter sunscreen.
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Regulatory Intelligence & Drug Approvals6 days agoEpidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.
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Clinical Trials & Development6 days agoM3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)
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Regulatory Intelligence & Drug Approvals6 days agoFDA-TRACK: Expanded Access (Compassionate Use) Submission Data
FDA-TRACK: Expanded Access (Compassionate Use) Submission Data
Ensuring safety and accountability in China’s biomedical translation system
Blood centers can help biopharma scale cell and gene therapies
Psychedelics at FDA, Mike Davis’ CDER and translating tRNAs — a BioCentury podcast
Scientists turn pig semen extract into eye drops that kill cancer in mice
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
