Regulatory Blog

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USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance...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

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...