US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes

2024-02-29T16:44:37+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , , , , , , |

The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]

FDA Finalizes Guidance for Premarket Pathways for Combination Products

2023-03-29T14:06:37+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: , , , , , , |

The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]

New FDA guidance: Good ANDA Submission Practices

2023-03-29T14:26:12+00:00February 1st, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , |

The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices. "This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, [...]

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]

US: FDA provides examples on real world evidence to support marketing applications for medical devices

2024-02-29T16:54:30+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: , , , , |

The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices. The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption [...]

US: CDRH plans full launch of ASCA pilot program in 2021

2023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: , , , , |

The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business [...]

US: FDA introduces new Medical Device Development Tools for sponsors

2024-02-29T16:45:09+00:00October 22nd, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: , , , |

The FDA introduced a new Medical Device Development Tools (MDDT) for the investigation of medical devices. Through the MDDT program, the FDA defines tools that medical device sponsors can use in the development and evaluation of medical devices. The [...]

The International Medical Device Regulators Forum (IMDRF) issued an update on PMCF studies

2024-02-29T14:41:05+00:00October 21st, 2020|Categories: Clinical Trial, Europe, USA|Tags: , , , , |

The International Medical Device Regulators Forum (IMDRF) has issued an update proposal to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices. The proposal will be open for consultation untill 11 December 2020. The update includes advice [...]

US: FDA launches the Digital Health Center of Excellence

2024-02-29T16:51:55+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: , , , , |

The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering the [...]

US: FDA updates the guidance on the conduct of clinical trials during COVID-19 pandemic

2024-02-29T17:09:11+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: , , , , |

FDA provided an update to the guidance on the conduct of clinical trials during COVID-19 pandemic. The update aims at providing "general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice [...]

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