Quality Systems

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.

Best practices for buying, selling, and transporting second-user equipment.

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.

The agency has recommended marketing authorization for Ibrance in the European Union.

In response to the EpiPen pricing scandal, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, clarifies FDA’s role in drug pricing.

Industry concerns have generated efforts by FDA to streamline the system for designating the lead center to regulate a new combination product.

Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling batches of hyoscyamine sulfate (0.125mg).

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

The agency provides a qualified context of use for the biomarker plasma fibrinogen.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

The company voluntarily recalled the product due to detached needles on the syringe in the kit.

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.