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Human Drugs

WLF Asks End to California Patent Settlement Law

Washington Legal Foundation asks the 9th Circuit Court of Appeals to enjoin a California law that presumes most drug patent settlements are unlawful....

Human Drugs

OPQ Looks at Five Years of Success

The Office of Pharmaceutical Quality 2019 annual report looks at the progress made in the organizations five years of existence.

Human Drugs

FDA Lifts Marker Therapeutics Trial Hold

FDA lifts its clinical hold on a Marker Therapeutics trial of its novel MultiTAA T-cell therapy for some acute myeloid leukemia patients.

Human Drugs

Erectile Dysfunction Drug Notice Sought

The Physicians Committee for Responsible Medicine asks FDA to require specific wording in labeling and packaging for erectile dysfunction drugs discus...

Medical Devices

Rist Cath Radial Access Long Sheath Cleared

FDA clears a Rist Neurovascular 510(k) for the Rist Cath Radial Access Long Sheath and its use to introduce interventional devices into the peripheral...

Federal Register

Info Collection on Device Safety Communications

Federal Register notice: FDA sends to OMB an information collection extension on Testing Communications on Medical Devices and Radiation-Emitting Prod...

Federal Register

Info Collection on Social/Behavioral Research

Federal Register notice: FDA seeks comments on a new information collection for qualitative data to support social and behavioral research for certain...

FDA General

Trump Budget Proposes Flat $6.2 Billion FDA Budget

President Trump proposes a relatively flat (1.6% increase) $6.2 billion budget for FDAs fiscal year 2021 budget, which includes $3.3 billion for budge...

FDA General

FDA Phone Safety Review: No Adverse Health Effects

A new FDA literature review on cell phone radiofrequency radiation exposure on human health finds no quantifiable adverse health effects.

Human Drugs

Lilly Reports Miss on Alzheimers Study

Eli Lilly says it does not plan to pursue an NDA submission for solanezumab for treating patients with dominantly inherited Alzheimers disease based o...