Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...

USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19

On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...

USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests

Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...

China Approves Oral pill COVID Antiviral-Azvudine

Earlier Monday, China's drug regulator granted conditional approval for an HIV drug to treat COVID-19. This is the first oral antiviral...

MHRA’s updated Guidance on URGENT SAFETY MEASURE – UK

This guidance has been developed to assist those involved in clinical trials disrupted as a result of COVID-19. It is relevant to those...

USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA

On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...

Assessment & Decision Process for the Recognition of a Conformity Assessment Body -IMDRF

International Medical Device Regulators Forum (IMDRF) published a final document describing the “Assessment and Decision Process for the...

Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA

The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...

FDA Offers guidance on Generic Drug Development- COVID

US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing...