Quality Systems

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.

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

Why critical thinking must be applied before technology to ensure regulatory compliance.

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.

Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.