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Article FDA Thank You In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue

Agency IQ

In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue Two lower courts had articulated a Rube Goldberg-esque theory of “standing” – the right of a person or organization to sue another entity – based on the idea that doctors not prescribing mifepristone or treating patients who had taken it had experienced economic harms.

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Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19

The Pharma Data

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

Kathryn E Wellen, PhD – Outstanding Achievement in Basic Cancer Research Wellen is an investigator at the Penn Epigenetics Institute and Vice Chair and Professor in the Department of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET.

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Beyond blood tests: The evolution of digital biomarkers in clinical research

Drug Discovery World

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. In certain cases, to pinpoint the specific type of ILD and its severity, doctors might recommend a lung biopsy. The potential of these digital tools is vast.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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How large language models can elevate clinical research

Drug Discovery World

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. By employing LLMs innovatively, COLT not only streamlines the data management process but also accelerates the pace at which clinical trials can deliver actionable insights, ultimately advancing the field of cancer treatment.