Regulatory Blog

Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...

Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...

Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...

On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....

The South African Health Products Regulatory Authority (SAPHRA) did a few Administrative updates and amendments in its Post-marketing...

On 15-June-22, the HPRA released a guide on how to Performance Studies Conducted in Ireland. The term ‘performance study’ (PS) is defined...

According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...

FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...

Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...

On 3 June, USFDA's Center for Devices and Radiological Health & Center for Biologics Evaluation and Research released updated guidance...

According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...

On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...

The International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group Proposed document...