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Navigating FDA's clinical trial expectations after approval
Manage episode 434037207 series 3506216
תוכן מסופק על ידי Darshan Kulkarni. כל תוכן הפודקאסטים כולל פרקים, גרפיקה ותיאורי פודקאסטים מועלים ומסופקים ישירות על ידי Darshan Kulkarni או שותף פלטפורמת הפודקאסט שלהם. אם אתה מאמין שמישהו משתמש ביצירה שלך המוגנת בזכויות יוצרים ללא רשותך, אתה יכול לעקוב אחר התהליך המתואר כאן https://he.player.fm/legal.
Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs).
PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-world setting. PMCs, while not legally mandated, are additional studies agreed upon by the drug developer, providing valuable insights.
Both PMRs and PMCs are essential for ensuring the safety and efficacy of medications.
For clinical research sites, adhering to these protocols can be challenging but offers opportunities to showcase expertise and attract more research partnerships.
For Sponsors: Sponsors must manage the costs and potential delays, but the insights gained can strengthen product value and regulatory trust.
For CROs: CROs need to stay compliant and adapt to these requirements to secure lucrative collaborations.
Join us as we explore the latest FDA report and its implications for everyone in the clinical research arena. Don't miss out on understanding how these regulations shape the future of medical treatments and industry collaborations!
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