Quality Systems

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.

A new report gives an overview of the work of the International API Inspection Program.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.