Newsletter | August 22, 2024

08.22.24 -- What To Expect After An FDA 483

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Webinar: Revolutionizing Patient Recruitment for Clinical Research Sites

Inefficiencies in patient recruitment for clinical research sites lead to significant costs and low enrollment rates. With $1.9 billion spent annually, 48% of sites enroll few or no patients, and 72% of participants are already site patients. Discover how to optimize patient recruitment through strong site relationships, expertise, and technology, while addressing workforce challenges and best practices for trial design and patient enrollment. Click to learn more.

OUTSOURCING MODELS

Quality Assurance Strategies For Clinical Trials In Low- And Middle-Income Countries

This author shares key learnings and insights around quality assurance coming out of Gates MRI's vaccine clinical trials in low- and middle-income countries.

Critical Supply Strategies For CROs

Leveraging the expertise of a chosen clinical supply partner can be a valuable resource. Examine key considerations when partnering with a CRO in order to deliver a successful clinical supply strategy.

On-Site Pharmacies: Maximizing Efficiency In Translational Medicine

Having the capability to modify the early stages of drug development in real time, based upon observed clinical and pharmacokinetic data, is crucial and can be effectively managed with an on-site pharmacy.

Packaging Design And Development Services

We are manufacturing, packaging, and supply chain experts, harnessing experience and expertise to deliver you a seamless solution with the ultimate aim of improving the lives of patients.

REGULATORY & COMPLIANCE

What To Expect After An FDA 483

Vincent Cafiso, a former FDA investigator, talks about what to do after an FDA inspection of your clinical trial site. “Don’t expect you’re not going to get a 483,” he says. But how you react to that 483 can deeply affect your company —possibly — for years to come.

Bridging The Gap: Breaking APAC Into The US FDA Market

For APAC companies, it's important to identify the differences in care standards, formulate strategies for compliance, and develop solutions to bridge the regulatory gap and realize FDA approval.

How Regulatory CMC Experts Navigate Accelerated Approval Timelines

Despite adjusted timelines, stringent manufacturing and characterization requirements for product safety and quality remain, necessitating proactive planning to meet deliverables.

Regulatory Lifecycle Management (LCM) Services

Managing regulatory compliance for mature products while driving growth through new product development requires careful balance.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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