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Fit-For-Purpose Clinical Outcome Assessment Guidance

FDA publishes a draft guidance to help sponsors develop fit-for-purpose clinical outcome assessment measures of patients health that are appropriate t...

Federal Register

FDA Determines Regulatory Review Period for Rukobia

Federal Register notice: FDA determines for patent restoration purposes the regulatory review period for ViiV Healthcares Rukobia (fostemsavir trometh...

Federal Register

Regulatory Review Period for Danyelza

Federal Register notice: FDA determines for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics Danyelza (naxitamab-...

Human Drugs

FDA Will Review Eylea sBLA for an Extended Dosing Regimen

FDA sets 2/28/23 as the target date for its review of a Regeneron sBLA for a 167-week dosing regimen of Eylea in patients with diabetic retinopathy.

FDA General

Attorneys See Renewed DoJ Interest in Fraud-on-FDA

A Duane Morris legal alert says the Justice Department is showing a renewed interest in fraud-on-FDA cases.

Human Drugs

Improve FDA Foreign For-Cause Inspections: OIG

The HHS Inspector General says FDA agrees with its recommendations to improve foreign for-cause drug inspections.

Medical Devices

Invictus Sterilization Air Purifier Cleared

FDA clears an Invictus Sterilization 510(k) for the Aura Storm ultraviolet medical air purifier that is intended to inactivate bacteria and viruses (e...

Human Drugs

Santhera Pharma Delays NDA Over Inspection Readiness

Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy has been postponed by four to six months aft...

Human Drugs

100 Members of Congress Want HHS to Lower Drug Prices

Some 100 members of Congress call on HHS to use existing legal authorities to lower drug prices in the U.S.

Human Drugs

2 Drugs Have Positive Effect on Alzheimers Disease: Study

University of Colorado researchers say they have identified two FDA-approved drugs that may help prevent Alzheimers disease and improve cognition in A...