Regulatory Blog

The Swissmedic guidance released an information sheet titled " Combined Studies: Clinical Investigations of Medical Devices, Medicinal...

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...

Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...

The Medical Device Coordination Group (MDCG) has released guidance " Application of MDR requirements to ‘legacy devices’ and to devices...

The Medical Device Coordination Group (MDCG)  has released its updated guidance and templates for conformity assessment bodies, notified...

The Medical Device Coordination Group (MDCG)  has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...

The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...

USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...

India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...

USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance...

The USFDA  (U.S. Food and Drug Administration) Center for Devices and Radiological Health provides detailed final guidance " Appeal...

The advancement of Artificial Intelligence (AI)  is transforming many industries, and the pharmaceutical and regulatory sectors are no...

USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and Center for Devices and Radiological Health ...

India has recently made significant advancements in its healthcare regulatory landscape by launching two new online portals " Adverse...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...

Yesterday the U.S. Food and Drug Administration (FDA) has released critical guidance documents to streamline the regulatory pathways for...

The U.S. Food and Drug Administration (FDA) has released a guidance document titled " Predetermined Change Control Plans for Medical...

The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on " Medicines Pipeline Data " on 13 August, 2024 to...

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...