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2 Pfizer sNDA Submitted for Lung Cancer Drugs

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FDA accepts for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients...

OCP IND Prioritization, Triage Guidance

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CDER issues an updated MAPP for Office of Clinical Pharmacology IND review processes.

Guide on Animal Drug Human Safety Assessments

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FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of th...

Abbott Safety Notice on FreeStyle Libre Readers

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Abbott issues a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeS...

Tavo-EP/Keytruda Fails Phase 2 Melanoma Trial

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OncoSec says its Tavo-EP in combination with Mercks Keytruda failed to meet the overall response rate primary endpoint in a Phase ...

Synovo Adulterated, Misbranded Products

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FDA warns Fullerton, CA-based Synovo Production about its manufacturing and distribution of adulterated and misbranded orthopedic ...

FDA Consistent in Implementing NME Communications

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Lilly researchers say FDA was consistent in meeting its mid-cycle communication goals under a 2012 program to educate regulatory p...

EUA for Gohibic for Some Hospitalized Covid Patients

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FDA approves an emergency use authorization for InflaRxs Gohibic to treat some hospitalized Covid-19 patients.

BC3 Tech Clears SEAL Rapid Wound Spray

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FDA clears a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray.

Opioid Makers Must Provide Mail-back Envelope

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FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and...