Quality/GMPs

The agency cited the company for sterile manufacturing violations.

The two agencies have set up a working group on involving patients in drug development.

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

The agency published a report on fostering the development of advanced therapy medicinal products.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.

An understanding of continuous process validation can lead the way to consistent approaches, reduced investigation times and observations, the avoidance of lost batches, and high-quality products.

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.