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Human Drugs

China API Supply Disruption Over Coronavirus: Survey

A survey of China-based active pharmaceutical ingredient makers and worldwide users indicates that suppliers may experience some disruptions during th...

Human Drugs

Genus Lifesciences Asks Court to Toss Lannett Drug Approval

Genus Lifesciences asks the DC federal court to rule that FDA unlawfully approved Lannetts Numbrino during a time when Genus had NCEE exclusivity for ...

Human Drugs

Wave Miami Distributing Unapproved New Drug: FDA

FDA warns Wave Miami that it is distributing an unapproved and misbranded new drug containing an undeclared erectile dysfunction drug.

Human Drugs

FDA Launches Interactive PEPFAR Database

FDA launches a mobile-friendly database with information, including labeling, on antiretroviral drugs approved for use in the PEPFAR program overseas.

Human Drugs

Novartis Walks Away from Generic Advair

Novartis says it is abandoning its development program for a generic copy of GlaxoSmithKlines Advair Diskus (fluticasone propionate/salmeterol).

Medical Devices

Sony Operating Room Imaging Platform Cleared

FDA clears a Sony Electronics 510(k) for its Nucleus Operating Room Imaging Management and Collaboration Control platform.

Biologics

Court Denies FDA Move Against California Stem Cell Clinics

A California federal judge says an FDA suit against two California stem cell clinics should go to trial to determine whether the agency has regulatory...

Human Drugs

Study Supports GCSF Use in Treating Strokes

A study from Florida Atlantic Universitys Schmidt College of Medicine finds that granulocyte colony-stimulating factor or Amgens Neupogen may offer a ...

Federal Register

DTC Study on Ad Endorser Influence

Federal Register notice: FDA seeks comments on a proposed study entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion....

Federal Register

Guide on Arthroscopy Pump Tubing Sets

Federal Register notice: FDA makes available a draft guidance entitled Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use Premarket Notif...