Regulatory Focus

The US Food and Drug Administration (FDA) recently issued warning letters to three manufacturers of active pharmaceutical ingredients (APIs) based in China. Two of the companies were warned for refusing to comply with the FDA's requests for records, while the third was cited for lacking appropriate quality oversight of the raw ingredients.

The US Food and Drug Administration (FDA) is requesting feedback on possible solutions that would help sponsors more effectively submit patient-level real-world data (RWD) and real-world evidence (RWE) for drug and biological product applications.

BARCELONA – Experts said that specialized artificial intelligence (AI) tools can be invaluable in helping companies address regulatory needs for medical devices, while saving time and money, during a panel discussion at the RAPS AI in Regulatory Conference. However, they noted significant limitations of such tools, which ultimately rely on subject matter experts being in control of the AI.

The European Medicines Agency (EMA) is seeking feedback on the information needed for the approval of biomarker-guided medicinal products.

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The US Food and Drug Administration (FDA) has issued draft guidance to assist sponsors in developing early-phase first-in-human (FIH) studies for investigational drugs and biologics aimed at treating solid tumors as part of Operation TrialBlazer.

BARCELONA – Experts noted that companies shouldn’t wait until a law is enacted to begin developing regulatory intelligence. Instead, they recommended that regulatory professionals engage with key stakeholders early to ensure they are prepared to implement the regulations and have a say in their implementation.

Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas said there is significant public interest in its recently announced Expedited Investigational New Drug (IND) pilot at the Friends of Cancer Research (FOCR) annual meeting on Tuesday.