Regulatory Oversight and Compliance

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

What does the 2024 VPAS mean for pharma?

FDA and industry face unprecedented political and policy challenges.

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

Exagamglogene autotemcel seen as synechdoche.

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

The EC is calling for interested parties for their safety and orphan drug committees.

A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.