Quality Systems

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.

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.