August: normally full of summer… sun, sand and surf. As the song goes, “summertime and the living is easy…” In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business... Read more
Business Intelligence Solutions Interview with Jack Garvey FDA INSPECTION READINESS March 2010 What are the biggest issues currently facing FDA-regulated companies when it comes to FDA inspections? FDA regulated companies are currently dealing with a multitude... Read more
Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of... Read more
Although audits, assessments and corporate compliance investigations are not something most executives get excited about, they are critical to ensuring your FDA-regulated business is ready for any and all types of review by the FDA, Department of Justice... Read more
