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Federal Register

Workshop on Drug-caused Blood Pressure Effects

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

Federal Register

Guide on Nonmetastatic, Castration-Resistant Prostate Cancer

Federal Register notice: FDA makes available a draft guidance entitled Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metasta...

Human Drugs

Memory Supplements Failed Lab Tests: GAO

The Government Accountability Office says laboratory testing of three dietary supplements marketed to improve memory did not contain ingredients and q...

Human Drugs

FDA OKs Allergy Drug for Younger Patients

FDA approves Stallergenes Greers Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) for t...

Medical Devices

Canon Medical Vantage Orian MRI Cleared

FDA clears a Canon Medical Systems 510(k) for its new premium MRI system, Vantage Orian 1.5T.

Medical Devices

3 Internatl. Device Reg. Documents Released by FDA

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

Medical Devices

FDA Cautions on Pain Management Pump Use

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

Human Drugs

Lilly NDA for Migraine; Plans sBLA for Cluster Headaches

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

Human Drugs

California Appeals Court Reverses Drug Preemption Case

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

FDA General

Ultragenyx Pharmaceutical Plans NDA Mid-2019

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