Quality Systems

Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.

The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.

The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.

Value assessment initiatives are expected to have a major impact on drug use and reimbursement.

FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.

The company is voluntarily recalling all unexpired lots of 50-mm, 0.2-micron filters.

EDQM and the Japanese Pharmacopoeia will improve the sharing of information on therapeutic products that are common in both Europe and Japan.

Efforts to accelerate drug development will alter fee structure and require ready production sites.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.

As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.

Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.

As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.

Could grading finished-drug manufacturers on their quality and efficiency lead to greater transparency, improve quality and reduce drug shortages?

Employee empowerment is needed and it begins with senior leaders making adherence to cGMP regulations and compliance with SOPs the normal, easy, and rewarding thing to do.

FDA and EMA set up new working group on the development of treatments for rare diseases.

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.

NICE estimates asfotase alfa will cost £367,000 per patient per year.

The agency published the guidance to help generic-drug facilities comply with the GDUFA self-identification requirement.

The agency has confirmed that patients who take plasma- or urine-derived drugs are not at increased risk for Zika.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

The agency clarifies how FDA determines when a risk evaluation and mitigation strategy is necessary.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

EMA has recommended halting supply of non-critical drugs from Pharmaceutics International Inc. because of GMP failures.

The agency recommended approval of 11 drugs, including three cancer drugs, in September.

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.