Regulatory/GMP Compliance

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.

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.

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 agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

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

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.

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

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

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

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

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.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

White House proposal includes measure to make drugs more affordable.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.