Quality Systems

The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

FDA is moving to shift industry away from step-wise batch production.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Better drug design and patient education may promote improved personal and public health.

Pharmaceutical Technology spoke with Roger Croucher, senior manager, R&D projects, at Catalent Pharma Solutions; Daniel M. Bowles, senior director, chemical development, at Cambrex; and Kurt J Kiewel, director, new product development and analytical services, also at Cambrex about best practices for a successful technology transfer.

Successful technology transfer depends on the ability to anticipate risks and plan ahead.

Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.

Modified-release oral dosage forms can offer benefits to both formulation scientists and patients.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

Microsaic Systems showcased its new MiD ProteinID point-of-need mass spectrometer at Pittcon in Philadelphia, PA, from March 18–21, 2019.

Sartorius introduced the Cubis II portfolio of laboratory balances at Pittcon 2019 in Philaphelia, PA.

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.

Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.

A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.