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Biologics

17 Issues In Invitrx Inspection

FDA warns Invigtrx Therapeutics about 17 deficiencies in its processing of products for allogeneic use.

Human Drugs

Mallinckrodt Rolling NDA for Terlipressin

Mallinckrodt completes a rolling NDA submission for terlipressin, an investigational agent being evaluated for treating hepatorenal syndrome Type 1.

Medical Devices

BodyGuard Infusion Sets Recalled

CME America recalls its BodyGuard Microset Infusion Sets due to potential medication flow restrictions.

FDA General

FDA Postpones Domestic Surveillance Inspections

Due to coronavirus concerns, FDA temporarily postpones all domestic routine surveillance facility inspections due to agency staff and company personne...

Conducting Clinical Trials During Pandemic

FDA says a guidance on conducting clinical trials during the Covid-19 pandemic takes effect immediately.

Human Drugs

FDA Loses Eagle Orphan Drug Appeal

The DC Circuit Court of Appeals rules against FDA in a suit challenging the agencys denial of orphan drug exclusivity for Eagles Bendeka.

Human Drugs

More Pediatric Oncology Guidance Info Sought

Two drug trade associations suggest ways FDA could improve a draft question-and-answer guidance on pediatric study plans for oncology drugs.

Human Drugs

Data Reporting Case Analyzed

Ropes & Gray analyzes a federal court decision that could force companies to submit 10 years worth of clinical trial results to Clinical Trials.gov th...

Federal Register

Guide on Liquid Drug Flow Restrictors

Federal Register notice: FDA makes available a draft guidance entitled Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.