Quality Systems

Articles

Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

EMA Recommends mAb for Treatment of Hereditary Angioedema

The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.

EMA Recommends Six Medicines for Approval

This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.

Strategies for Managing the Impact of Brexit for US Biotech Companies

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

Recipharm Releases First Serialized Products to Europe

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

FDA Releases Guidance on Targeted Therapies

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.

MHRA Seeks Views on ‘No-Deal’ Brexit Legislation and Procedural Changes

Agnes Shanley is senior editor of Pharmaceutical Technology.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

Sartan Recalls Beg the Question: Is Compendial Impurity Testing Enough?

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

The Link Between Data Integrity and Quality Culture

Sean Milmo is a freelance writer based in Essex, UK.

A European task force outlines its upcoming efforts to combat drug shortages.

Curbing Drug Shortages in Europe

As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.

Regulatory/GMP Compliance, Europe