Quality/GMPs

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.

The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

RGtimeline/Shutterstock.comParenteral product quality is improving.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.

More diversified therapies and tighter payer budgets will challenge bio/pharma companies to think outside the industry.

The company’s close communication with customers has enabled it to bring advanced pipetting products to market.

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.