|Outsourcing Options for Small Sponsors
Polaris Compliance Consultants
Strategic partnerships between large Sponsors and CROs can make it difficult for smaller sponsors to receive the quality of service and level of commitment they’re looking for. What can smaller pharmaceutical companies do to secure the outsourcing resources they require? [Read more.]
Free FDA Conferences
FDA is once again offering its extensive 3-day Investigator Training course November 7-9. Not your typical GCP agenda, this course features current, pragmatic instruction for conducting successful clinical trials. Science meets compliance. (And how great is it that they rhyme?)
FDA Small Business and Industry Assistance (SBIA) is hosting its Regulatory Education for Industry (REDi) conference September 27-28, which you can attend live or remotely. The agenda focuses on regulatory issues and requirements for both drugs and devices, and is pre-approved for RAPS credits. Keynote by FDA Chief Dr. Robert Califf.
Why is CRISPR All Over the News?
Because this gene editing technology is 99% faster and far more precise than previous techniques. This short, well-written guide explains how CRISPR exploits the cell’s innate ability to gene edit, something it does routinely to hunt out and kill viruses. The benefits for fighting disease could be world changing. So could some of the ethical implications.
Two Draft Guidances: Devices and Supplements
FDA published a draft guidance for determining whether a software change to a medical device requires a new 510(k) submission. Even with decision flowcharts and plenty of examples, this can still be tricky to figure.
What’s new in this draft guidance on New Dietary Ingredients? FDA is prepared to compile an authoritative list of dietary ingredients from pre-DSHEA days that are regarded as safe and therefore exempt from notification requirements.
Overwhelmed by the flood of biosimilar articles hitting the industry news? Zachary Brennan’s explainer piece provides the necessary context for readers to appreciate discussions of the current issues surrounding biosimilars, such as naming, labeling, and pharmacy substitution, and how much state legislation varies. After you read it, you’ll want to bookmark it.
Why Do We Get Carsick?
"Recent research has found that car sickness could be the result of your brain responding to what it thinks is a sudden bout of poisoning."
Proposed Rule for GLP
In late August, FDA issued its proposed GLP amendment requiring a Quality Systems approach to pre-clinical studies. The amendment calls for some new SOPs and additional management oversight responsibility not currently required.
- We're proud to announce that Lisa Olson has joined our staff as a CSV/Part 11 auditor. You may know Lisa from her former position as Director of Project Quality Management and QA at PAREXEL International. Now she brings her 35 years of experience in CSV and QA to Polaris.
- Lauren Kelley will be delivering two presentations at SoCRA’s annual conference at the end of September: Preparing for Successful Sponsor Audits and Exceptions from Informed Consent (EFIC). If you're attending SoCRA and want to meet up, drop Lauren a line.
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