Quality Systems

The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

Tracking and implementing label changes are crucial to the lifecycle of a marketed drug product.

As mergers continue and operations become more complex, simplifying procedures and training can prevent costly morale, quality, and compliance problems.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

Pressures on FDA will affect industry’s success in bringing new therapies to market.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.

Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector.

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.

The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.