Quality Systems

FDA staffers will be hard-pressed to process and review the wave of new drug application submissions in pre-established timeframes for action.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has made two significant changes to its new 2019 Code of Practice with the aim of boosting business integrity on a global scale.

The Qualit-e Cloud web portal allows for secure uploading and sharing of quality documents for raw materials.

Industry investment and regulatory support combined to move many important new medicines to market.

The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.

Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

The Steritest NEO device from MilliporeSigma provides safer pharmaceutical product testing through additional features.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP because of N-nitrosodiethylamine (NDEA) in the final drug product.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

Pricing pressures, investment volatility, and government disfunction greet Pharma in 2019.

This year promises to bring more focus on risk management and building a quality culture, says consultant Susan Schniepp.

Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.

FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.

Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.

Core functions and those funded by FY 2018 user fees are continuing, and 59% of the Agency’s staffers are being retained.

FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

Despite ongoing efforts to address drug shortages, FDA now sees a rise in active shortages and in the duration of supply problems.

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.