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1st Year Generic Drug Cluster Accomplishments

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

Share All Cancer Drug Approval Data: Study

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

FDA Accepts ImmunityBio BLA

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

Lexicon Re-files NDA for Heart Failure Drug

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

Cannabis Administration and Opportunity Act

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Senate leaders introduce the Cannabis Administration and Opportunity Act.

Breakthrough Designation for Vertex Pain Drug

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

Objectionable Conditions in Goodman Eye Center Trial

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

Neonatal Study Pharmacology Considerations

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

Guide on LASIK Patient Labeling Recommendations

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FDA issues a draft guidance to help ensure that information is available to patients and health care professionals to clearly comm...

Ivax Pharmas Chloramphenicol Withdrawn Over Safety

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Federal Register notice: FDA withdraws the approval of Ivax Pharmaceuticals ANDA for chloramphenicol capsules (250 mg) after the c...