PHILADELPHIA — Exposure to wildfire smoke is linked to a 21% increased risk for dementia, early results from a large, longitudinal study suggest. The risk appears […]
PHILADELPHIA — Amyloid beta (Aβ) and tau protein blood biomarkers are highly accurate in identifying Alzheimer’s disease (AD) in patients with cognitive symptoms attending primary and […]
Docket Number: FDA-2010-D-0133 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors planning to conduct studies to […]
Docket Number: FDA-2013-D-0362 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products This guidance document is […]
About FDA Guidances Guidance documents represent the Agency’s current thinking on a particular subject. They do not create or confer any rights for or on any […]
Docket Number: FDA-2021-D-1128 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for […]
AstraZeneca was taken to task last week by the US Food and Drug Administration’s (FDA’s) Oncology Drug Advisory Committee (ODAC) for failing to heed an agency […]
MUSIC: IN Narrator: Unused medicines can spell many things. RISK, if they’re taken by someone they weren’t prescribed for. HARM, if accidentally taken by a child […]
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