Quality Systems

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.

GMP non-compliance can spill over and impact patient access to life-saving medications.

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.

FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company’s Morgantown, WV, facility.

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

Leaders of the two parties are open to challenging the status quo on drug costs and spending.

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Survey results and record attendance show positive signs for various bio/pharma regions.

Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.

New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.

Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.

The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.

A new proposal aims to reduce reimbursement for medicines administered to seniors under the Part B benefit to an amount pegged to the average price paid in foreign industrial nations.