Quality/GMPs

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.

The agency sent a warning letter to Sal Pharma for not disclosing information about API manufacturers to customers.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

New study will reveal bio/pharma practices and performance on quality issues.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.

This article provides an overview on important aspects related to bracketing strategies in Japan.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward.

April 24–30, 2017 is European Immunization Week in Europe, and in a statement on the European Medicines Agency (EMA) website dated April 25, 2017, Executive Director Guido Rasi stressed the importance of vaccinations in preventing and controlling disease. Rasi acknowledged that fear created from incorrect information presented by unreliable sources has created a lack of trust in vaccines. But he highlighted that Europe monitors and records information on the safety of medicines, including vaccines.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.

Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.

The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

The number of deficiencies found in foreign and UK-based facilities increased in 2016.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

The agency cited the company’s India facility for batch failures and data integrity problems.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.

FDA is in the center of the debate over developing and pricing new cancer therapies.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

EMA has developed a framework and action plan to foster relationships with the academic community.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.