Regulatory/GMP Compliance

EFSA’s evaluation of risk in food products raises implications for drug product formulations.

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.