Quality Systems

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Impax Pharmaceuticals received FDA approval of Rytary for use in patients with Parkinson’s disease.

The FDA center released a list of the guidance documents it plans to publish in 2015.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to handle staff challenges to regulation requirements

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Valeant voluntarily recalled one lot of Virazole due to sterility problems; no adverse events have been reported to date.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.

Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.

Teva Pharmaceuticals announced that FDA approved Granix injection for self-administration in patients.

FDA announced that it approved a new antibacterial drug, Zerbaxa, for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.