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USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication
FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...
Sharan Murugan
Jun 16, 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
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
USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions
On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...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
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...
Sharan Murugan
Sep 11, 20211 min read
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...
Sharan Murugan
Aug 21, 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