Search
Sharan Murugan
Jul 7, 20211 min read
Final Guidance on Unique Device Identification System: Form and Content of the UDI – US FDA
The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique...
8 views0 comments
Sharan Murugan
Jul 5, 20211 min read
Draft guidance for Transdermal Adhesion Systems– US FDA
This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...
11 views0 comments
Sharan Murugan
Jul 5, 20211 min read
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...
10 views0 comments
Sharan Murugan
Jun 27, 20211 min read
Guidance on CMC Changes to an Approved Application- US-FDA
FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...
16 views0 comments
Sharan Murugan
Jun 27, 20211 min read
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...
8 views0 comments
Sharan Murugan
Jun 19, 20211 min read
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...
3 views0 comments
Sharan Murugan
Jun 11, 20211 min read
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
3 views0 comments
Sharan Murugan
May 28, 20211 min read
FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...
3 views0 comments
Sharan Murugan
May 28, 20211 min read
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...
13 views0 comments