Quality Systems

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

How confident are you in your lab results? This paper explores this question and, by way of a worked example, provides a methodology to answer it.

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation.

Technological advances hold promise for mitigating human error in the pharmaceutical industry, especially in quality assurance/quality control, by reducing the incidence of, and risk associated with, mistakes.

A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.

The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.

By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.

Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

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.