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Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. What is the number of FDA 483 observations involving deviation investigations (inadequate, incomplete, etc.)? Is this an area that FDA investigators […]

When it comes to GMP considerations, what are the regulatory requirements for cell and gene therapies? Cell therapies consist of autologous and allogeneic products. Autologous products are taken from an individual patient, modified, and then returned back to the patient in an effort to treat disease while allogeneic products are composed of donor cells delivered […]

When it comes to decentralized clinical trials (DCTs), risk-based monitoring is just as critical as it is for in-person clinical trials. [Related: Author Jerry Chapman recently presented the webinar, “FDA GCP Inspection Trends Identified Using AI,” which included analysis of FDA enforcement trends involving clinical investigators. The recording of this webinar can be accessed here.] […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. How frequent are FDA 483 observations involving clinical investigators’ paper record controls? As in other pharma operations (GMP comes to mind), […]

Design Controls are FDA-required procedures in 21 CFR 820.30 that govern every phase from design planning to validation, proving a medical device meets user needs and remains safe and effective. Regulators examine these records during inspections and cite gaps on Form 483s or Warning Letters. Table of Contents Definition & regulatory basis Why Are Medical […]

With decentralized clinical trials (DCTs), what responsibilities fall under sponsor oversight? At the Society of Quality Assurance 2022 Annual Meeting in Palm Springs, Calif. FDA Office of Regulatory Affairs Bioresearch Monitoring Division I Director Anne Johnson provided FDA’s perspective on DCTs in a presentation titled, “Sponsor Oversight of Decentralized Clinical Trials.” [Related: What can inspection […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. How many 483 observations over the past ten years involve cleaning validation? Cleaning issues, in particular, cleaning validation (steps to ensure […]

If you are evaluating a new contract manufacturing organization (CMO), do you know what to look for in a new CMO? Keep in mind that companies that outsource manufacturing operations are still responsible for ensuring quality. This means that it is critical to partner with the appropriate CMO. At the 2021 PDA/FDA Joint Regulatory Conference, […]

During the recent pandemic, as with many facets of life and business, the design and conduct of clinical trials adapted to limit physical contact between individuals—in this case, those conducting and participating in clinical studies. Many companies opted to use a format that has been around for some time but not frequently used: the Decentralized […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. How do repeat observations compare between North America and the Asia-Pacific regions? Repeat observations are FDA 483 observations from more than […]