Quality Systems

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Stockpiling excess inventory is no longer enough to respond to supply chain volatility.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

The further we pursue CGT, the more variability we need to account for in order to engineer consistency into these new products.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

Sanofi’s once-weekly replacement therapy is FDA-approved for prevention and treatment of bleeding episodes in people with hemophilia A.

GAO calls for more oversight of institutional review boards in clinical trials.

Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.

In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.

The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.

After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.

Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.

The change would impact every package and hundreds of systems.

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

Harmonization of global regulations fosters innovation and ensures quality medicines.

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

The European bio/pharma industry’s high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical‑grade manufacturing of cannabis-based medicines.

A new unified initiative for patent protection in the EU to boost the competitiveness of the pharma industry is nearing completion.