Quality Systems

Articles

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

FDA Approves First Over-the-Counter Naloxone Nasal Spray

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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

Feds to Review March-In Authority on Drug Patents

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Digital Health Technologies Document Outlines Framework for FDA

The decision was based on results from the PROpel Phase III trial.

Lynparza Approved in UK as Combination Therapy for Treatment of Metastatic Castration-Resistant Prostate Cancer 

This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

European Commission Approves Dupixent as First, Only Targeted Medicine for Children with Severe Atopic Dermatitis

Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.

EMA Management Board Continues to Monitor Critical Shortages of Medicines 

Podcasts

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: FDA Speaks About Near Patient and Continuous Manufacturing 

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

First Drugs Hit by Inflation Reduction Act Price Controls

Mike Wilson, QA/QC Strategy, Waters Corporation

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.

Mitigating Human Error and Supporting Compliance with Smart Technology

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon.

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

Regulatory Oversight and Compliance