Search
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...
Sharan Murugan
Oct 23, 20231 min read
18 views
0 comments
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...
Sharan Murugan
Mar 24, 20231 min read
17 views
0 comments
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...
Sharan Murugan
Sep 30, 20221 min read
8 views
0 comments
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...
Sharan Murugan
Jul 28, 20221 min read
20 views
0 comments
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...
Sharan Murugan
Nov 20, 20211 min read
332 views
0 comments
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...
Sharan Murugan
Sep 11, 20211 min read
10 views
0 comments
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...
Sharan Murugan
Jul 10, 20211 min read
3 views
0 comments
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...
Sharan Murugan
Jul 1, 20211 min read
10 views
0 comments
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...
Sharan Murugan
May 4, 20211 min read
9 views
0 comments