FDA Issues New Draft Guidance on Clinical Evaluation of Software as Medical Device
The U.S. Food and Drug Administration released updated guidance on May 13, 2024, that sets new expectations for…
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Federal drug and device approvals, safety alerts, and regulatory guidance.
FDA Reviews Safety Data After Emerging Adverse Event Reports for Widely Used Medication
The FDA has begun reviewing new adverse event reports tied to a prescription medication already on the market. Agency…
Read More →FDA Expands Regulatory Framework to Streamline Digital Therapeutic Approvals for Chronic Conditions
The FDA released updated guidance in May 2024 that refines how software functions for chronic disease management are…
Read More →FDA Authorizes First RSV Vaccine for Seniors to Reduce Severe Disease
The U.S. Food and Drug Administration approved the first vaccine against respiratory syncytial virus for adults aged…
Read More →CDC Revises Adult Immunization Schedule to Include RSV Vaccination Recommendations for Adults 60 and Older
CDC Updates 2024 Adult Immunization Schedule With RSV Recommendations for Older Adults
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