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3 Internatl. Device Reg. Documents Released by FDA

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FDA releases three International Medical Device Regulators Forum documents covering standards development, essential principles, a...

FDA Cautions on Pain Management Pump Use

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FDA cautions healthcare professionals about the risks of using non-FDA approved pain medicines in implanted pumps.

Lilly NDA for Migraine; Plans sBLA for Cluster Headaches

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Eli Lilly files an NDA for lasmiditan for the acute treatment of migraine and plans supplemental BLA for cluster headaches.

California Appeals Court Reverses Drug Preemption Case

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A California state appeals court says a lower court must consider new scientific evidence raised by plaintiffs who claim that thre...

Ultragenyx Pharmaceutical Plans NDA Mid-2019

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Ultragenyx Pharmaceutical completes a pre-NDA meeting and plans to submit an NDA for UX007 for treating patients with long-chain f...

8 Observations in Dr. Reddys FDA-483

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FDA releases an FDA-483 with eight observations from a recent inspection at a Dr. Reddys manufacturing facility in India.

Workshop on Drug-caused Blood Pressure Effects

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Federal Register notice: FDA announces a 2/4 public workshop entitled Evaluating the Pressor Effects of Drugs.

Guide on Nonmetastatic, Castration-Resistant Prostate Cancer

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Federal Register notice: FDA makes available a draft guidance entitled Nonmetastatic, Castration-Resistant Prostate Cancer: Consid...

Memory Supplements Failed Lab Tests: GAO

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The Government Accountability Office says laboratory testing of three dietary supplements marketed to improve memory did not conta...

FDA OKs Allergy Drug for Younger Patients

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FDA approves Stallergenes Greers Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens all...