Regulatory Oversight and Compliance

The agency has approved Boehringer Ingelheim’s Ofev (nintedanib), its lung disease drug, for the treatment of patients with systemic sclerosis associated with lung disease.

Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.

EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.

The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.

Equipment and systems for aseptic transfer and manufacture meet cGMP and Annex 1 requirements for pharmaceutical fill and finish.

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.

Industry and regulators seek global system that reduces regional differences.

Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.

EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

The supplemental new drug application seeks to add an indication for men with prostate cancer that has spread but is sensitive to hormone therapy.

Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.

GSK has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.

The US Pharmacopeial Convention is proposing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs.