Search
Updated Version of Clinical Outcome Assessment Compendium -USFDA
The COA Compendium is part of the FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate...
Sharan Murugan
Dec 11, 20211 min read
USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration
On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...
Sharan Murugan
Dec 5, 20211 min read
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...
Sharan Murugan
Nov 30, 20211 min read
Knowledge aided Assessment and Structured Application (KASA) Initiative
The current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of...
Sharan Murugan
Nov 7, 20211 min read
Draft Guidance for Device Software in Premarket Submissions - USFDA
This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...
Sharan Murugan
Nov 7, 20211 min read
USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance
The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and...
Sharan Murugan
Oct 3, 20211 min read
FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...
Sharan Murugan
Oct 3, 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On 28-September, 2021 USFDA released draft guidance to assist sponsors in using an electronic template for submitting a premarket...
Sharan Murugan
Sep 29, 20211 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...
Sharan Murugan
Sep 29, 20212 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...
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...
Sharan Murugan
Sep 23, 20211 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...
Sharan Murugan
Sep 14, 20212 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...
Sharan Murugan
Sep 8, 20211 min read
Expectations & Challenges in Conducting Virtual Inspections- USFDA and EMA
Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...
Sharan Murugan
May 8, 20211 min read