Quality/GMPs

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

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

Biologics have specific quality considerations that make fast tracking these drugs more difficult.

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

Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Exagamglogene autotemcel seen as synechdoche.

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, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.

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.

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

USP offers strategies to minimize residual impurities in downstream processing.

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

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

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

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

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.