Quality Systems

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Legislators have requested that FDA do more to prevent drug shortages.

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.

The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA and Congress seek to limit the production and distribution of pain medicines.

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.

Dissolution testing remains one of the pharmaceutical industry’s most straightforward, least expensive QC tools. Research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality.

Quality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.

The new kit is expected to detect a broad spectrum of pyrogens while offering high reproducibility and sensitivity as well as eliminating the need for live animal testing.

The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.

Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.

The new drug offers rapid and sustained control of patients’ potassium levels.

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.