Regulatory

Feb 06, 2018
By BioPharm International Editors
Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.
Feb 02, 2018
By BioPharm International Editors
The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.
Feb 01, 2018
BioPharm International
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Jan 23, 2018
By BioPharm International Editors
The latest continuing resolution funds the government for three weeks.
Jan 22, 2018
By BioPharm International Editors
Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.
Jan 16, 2018
By BioPharm International Editors
The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.
Jan 11, 2018
By BioPharm International Editors
The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
Jan 11, 2018
By BioPharm International Editors
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.
Jan 05, 2018
By BioPharm International Editors
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
Jan 05, 2018
By BioPharm International Editors
FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.
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