Regulatory Intelligence

AO Regulatory Consulting maintains an extensive library detailing the regulatory requirements for pharmaceutical and drug development companies. As a whole, these documents are referred to as regulatory intelligence and they include things like regulatory precedent, statutory requirements, policies, guidelines, and guidance. Monitoring and analyzing this library can lead to earlier strategic regulatory actions with the potential to significantly reduce your product development timeline. With a minimal 40 hour/month contract, AO Regulatory Consulting will give your company access to this valuable repository.

Watch this space for articles containing timely advice and information. If there is a topic you would like to know more about, contact us to request an article.

  • FDA Orphan Drug Designation (ODD)
    History and Background In 1983, US Congress passed the Orphan Drug Act as an amendment to the federal Food Drug and Cosmetic Act (FDC Act) to advance the development of drugs that demonstrate promise to diagnose or treat rare diseases or conditions. In 1993, FDA issued regulations in 21 CFR… Read more: FDA Orphan Drug Designation (ODD)
  • Clinical Dose Optimization
    In Oncology In oncology, dose finding trials started using 3+3 dose escalation/expansion to select the recommended phase 2 dose (RP2D) and determine the maximum tolerated dose (MTD) in the 1990s. The earliest treatments for cancer – cytotoxic chemotherapies – had a steep dose-response curve and limited drug target specificity. Due… Read more: Clinical Dose Optimization
  • FDA Expanded Access Programs
    History and Background Expanded Access Programs (EAP) are governed by 21 CFR 312, Subpart I and are also referred to as “compassionate use.” They are designed to allow use of investigational drugs outside a clinical trial for subjects who do not meet the requirements of active running trial(s). There are… Read more: FDA Expanded Access Programs
  • Is a Pre-IND Meeting really needed?
    If polled, most executive teams would say they don’t want to take the time to do a Pre-IND meeting before submitting an initial investigational new drug (IND) application. I get it, it takes time, and time is money. But consider it can take MORE time to get your IND through… Read more: Is a Pre-IND Meeting really needed?