Quality/GMPs

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Problems continue despite actions by regulators to better prevent and address drug shortages.

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

The debate surrounding drug pricing changes rages on.

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

An increase in applications for gene therapies is putting stress on FDA’s resources.

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.