July 29, 2024
Prescription stimulants are classified as Schedule II drugs under the Controlled Substances Act and associated with serious risks, including misuse, addiction, overdose, and diversion. Stimulants are […]
July 29, 2024
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 […]
July 29, 2024
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 […]
July 29, 2024
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 […]
July 29, 2024
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 […]
July 29, 2024
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 […]
July 29, 2024
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 […]
July 29, 2024
Sridhar Mantha, M.B.A., M.S., B.Tech.Director, Office of Strategic Programs Sridhar (Sri) Mantha, M.B.A., M.S., B.Tech., serves as Director of CDER’s Office of Strategic Programs (OSP). OSP […]
July 29, 2024
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 […]
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