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Federal Register

Animal Drug User Fee Rates

Federal Register notice: FDA sets fee rates and payment procedures for fiscal year 2023 for animal drug user fees.

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Human Drugs

Opioid Questions Continue to Dog Califf: AP

An AP report says FDA commissioner Robert Califf is facing skepticism that the agency will address the nations opioid crisis in a meaningful way.

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Human Drugs

1st Year Generic Drug Cluster Accomplishments

FDA reviews the first-year accomplishments and future plans for the multi-country Generic Drug Cluster.

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Human Drugs

Share All Cancer Drug Approval Data: Study

Researchers in the U.S. and Australia call for an update to transparency policies so that all individual participant data supporting oncology drug reg...

Human Drugs

FDA Accepts ImmunityBio BLA

FDA sets 5/23/23 as the target PDUFA action date for its review of ImmunityBios N-803 to treat some bladder cancers.

Human Drugs

Lexicon Re-files NDA for Heart Failure Drug

FDA accepts for review a Lexicon Pharmaceuticals NDA resubmission for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor for treating he...

Human Drugs

Cannabis Administration and Opportunity Act

Senate leaders introduce the Cannabis Administration and Opportunity Act.

Human Drugs

Breakthrough Designation for Vertex Pain Drug

FDA grants breakthrough therapy designation to Vertex VX-548 for some acute and neuropathic pain indications.

Human Drugs

Objectionable Conditions in Goodman Eye Center Trial

FDA warns Dr. Daniel Goodman about objectionable conditions in a clinical trial at his San Francisco, CA-based Goodman Eye Center.

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Human Drugs

Neonatal Study Pharmacology Considerations

FDA publishes a guidance to help drug sponsors who are planning to conduct clinical studies in neonatal populations.