Regulatory Blog

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...

Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...

On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...

The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...

The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...

WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...

The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...

Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses...

The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...

The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...

The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....

The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

The U.S. Food and Drug Administration, yesterday announced the release of a draft guidance, Essential Drug Delivery Outputs for Devices...

The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...

The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt...