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Draft Guidance on Remanufacturing of Medical Devices- USA-FDA
Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...
Sharan Murugan
Jun 26, 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This is a DRAFT GUIDANCE distributed for comment purposes only.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...
Sharan Murugan
Jun 19, 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The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
Sharan Murugan
Jun 11, 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...
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...
Sharan Murugan
May 28, 20211 min read
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