02.23.23 -- 8 Takeaways For FDA Inspections From The Omnibus Reform Act

With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on December 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

Explore how two new draft guidances clarify best practices for communication and provide a framework for identifying gaps in development programs that may result from the unique properties of the combination product.

For life sciences companies, regulatory compliance never becomes any less complex and stringent. Depending on the exact nature of your work and where you do business, multiple regulatory frameworks apply. Existing frameworks may be refined by regulators and governments, requiring life sciences businesses to update their practices.

Read about why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient populations, and the availability of top clinical institutions as trial locations.

Manufacturers with aging facilities and technologies are certainly in danger of being found by inspectors to not meet the requirement to remain “current” under cGMPs.

We support our corporate sponsors by providing both assessment and processing of SUSARS as per local and country requirements. We provide reliable reporting of adverse events, unbiased signal detection, and potential mitigation and risk management plans, based on any findings as requested. 

Learn how configurable and connected quality management solutions can securely track and manage incident and complaint logging, case investigations and processing, CAPAs, compliance documents, and audits.

One of Premier Consulting’s differentiating offerings is the portfolio analysis: a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio.

Discover how including footnotes is a common practice and one that contributes more to non-compliance than just about any other facet of the protocol.

Pharmacy sites might be well positioned within their communities to serve a wide swath of patients. But what about the scope of their therapeutic areas of study? Walgreens head of decentralized clinical trials, John Campbell, and CVS health senior VP of clinical trial services, Tony Clapsis, share each pharmacy’s current breadth of coverage.

Gain insight into why CROs must fully understand how the nuances of regulatory compliance, particularly clinical trial disclosure, fit into and impact the entire lifespan of a study.

PCI's team of qualified persons assumes responsibility for all stages of the process, safeguarding patients, including the audit of the supply chain for GMP compliance, in addition to certification of products for use in clinical trials.

Our experts in the design and conduct of clinical pharmacology and early efficacy studies ensure that data generated meet your objectives.

Avance Clinical provides an efficient and compliant system in clinical trials with broader PV services by selecting Oracle Argus.