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USFDA: 3 updated Guidance on PLAIR, VQIP & Recalls
As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...
Sharan Murugan
Mar 6, 20222 min read
USFDA Guidance: Methods to Identify What Is Important to Patients
On 28-February-2022, the US Food and Drug Administration (FDA) finalized guidance to assist sponsors in collecting and submitting...
Sharan Murugan
Mar 3, 20221 min read
US FDA CDER Guidance Agenda -Calendar Year 2022
In 2022, CDER will publish new and revised guidances in its Guidance Agenda, which was released on January 31, 2022. The 2022 list...
Sharan Murugan
Feb 13, 20221 min read
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...
Sharan Murugan
Feb 6, 20221 min read
USFDA Guidance on Premarket Review of Combination Products
US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...
Sharan Murugan
Feb 6, 20221 min read
Guidance on Revising ANDA Labeling Following Revision of the RLD Labeling
This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling...
Sharan Murugan
Feb 6, 20221 min read
Patients’ Experiences & Engagements Medical Device Guidances - USFDA
US FDA issued two medical devices (final guidance documents on January 26, 2022, to help sponsors better incorporate and capture...
Sharan Murugan
Jan 27, 20221 min read
USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review
FDA published a series of guidances on January 26, 2022 focussing on Generic Drug Application Submissions, Labeling, and Review. These...
Sharan Murugan
Jan 27, 20221 min read
First Oral Antiviral (PFIZER) for Treatment of COVID-19 -USFDA
Yesterday U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...
Sharan Murugan
Dec 23, 20212 min read
Unannounced Inspections in India And China to be Resumed Soon: USFDA
Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...
Sharan Murugan
Dec 18, 20211 min read
Guidance for Residual Solvents: Q3C(R8) Impurities
This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...
Sharan Murugan
Dec 18, 20212 min read
CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA
This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...
Sharan Murugan
Dec 18, 20211 min read
USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions
On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...
Sharan Murugan
Dec 11, 20211 min read
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...
Sharan Murugan
Dec 11, 20212 min read
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