Quality/GMPs

Agency guidance and industry standards aim to reduce lapses and improve quality operations.

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

ICH detailed the highlights of the council’s June 2016 meeting.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

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.