Quality Systems

Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

FDA has accepted Dupixent for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.

ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.

Legislative proposals set the stage for debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

Standardization is needed in CAR-T cell therapy development due to its inherent complexity.

ViiV Healthcare announced that FDA has approved Triumeq PD, a dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Data may be used to improve (or remove) a corrective action/preventive action.

In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections.

Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.

Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.

Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity

Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.