Search
Sharan Murugan
Sep 29, 20211 min read
USFDA’s Electronic Submission Template for Medical Device 510(k) Submissions
On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...
25 views0 comments
Sharan Murugan
Sep 29, 20211 min read
India CDSCO -Guide for Manufacturers/Importers for Registration of Non-Notified Medical Devices
India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...
25 views0 comments
Sharan Murugan
Sep 29, 20212 min read
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...
26 views0 comments
Sharan Murugan
Sep 23, 20211 min read
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
On 20.09.2021, USFDA released an updated Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry. This...
233 views0 comments
Sharan Murugan
Sep 23, 20211 min read
Swissmedic- Updated Guidance on Authorisation of Human Med.Product with New Active Substance
On 17.09.2021, swiss medic released an updated Guidance on Authorisation of Human Medicinal Product with New Active Substance HMV4. The...
88 views0 comments
Sharan Murugan
Sep 23, 20211 min read
USFDA finalizes Q&As on Biosimilar Development
US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...
9 views0 comments
Sharan Murugan
Sep 17, 20211 min read
Denmark- Updated Guidance on Implementation Of Decentralised Elements In Clinical Trials
Decentralized clinical trials cover a multitude of elements that reduce, or in some cases even eliminate, the need for the trial...
44 views0 comments
Sharan Murugan
Sep 14, 20212 min read
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...
69 views0 comments
Sharan Murugan
Sep 11, 20211 min read
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...
10 views0 comments
Sharan Murugan
Sep 11, 20211 min read
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...
14 views0 comments
Sharan Murugan
Sep 8, 20211 min read
USFDA's Novel Excipient Review Pilot Program
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which...
16 views0 comments
Sharan Murugan
Sep 8, 20212 min read
Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has released guidance about the requirements and procedures of good...
311 views0 comments
Sharan Murugan
Sep 7, 20211 min read
Swissmedic Updates Forms for New Authorization, Variations & Extensions-Switzerland
On 01.09.2021, Swissmedic updated the forms for New authorisation of human medicinal products HMV4 and Variations and authorisation...
29 views0 comments
Sharan Murugan
Sep 5, 20211 min read
Updated Guidance for e-Submissions for CEP applications
As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...
26 views0 comments