The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.
The agency has published seven guidance documents directed at the development and manufacture of gene therapies.
The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.
The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.
As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.
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.
The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.
Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
The approval comes after the results of a clinical trial that showed 61% of patients had a response lasting six months or longer.
The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.
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.
While falling short of the 2018 record levels, US drug approval numbers continue to set the pace globally.
FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.
Pressures on FDA will affect industry’s success in bringing new therapies to market.
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.
The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.
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.
