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Sharan Murugan
Mar 20, 20242 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance...
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Sharan Murugan
Jun 8, 20231 min read
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...
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Sharan Murugan
Jun 5, 20231 min read
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...
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Sharan Murugan
Mar 28, 20231 min read
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...
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Sharan Murugan
Mar 11, 20231 min read
Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...
144 views1 comment
Sharan Murugan
Dec 27, 20221 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
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Sharan Murugan
Dec 2, 20221 min read
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...
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Sharan Murugan
Oct 22, 20222 min read
USFDA Guidances: Topical Generic Drug Products - ANDAs
Yesterday (October 21, 2022) USFDA Released multiple New draft guidelines providing guidance on topical generic drug product...
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Sharan Murugan
Oct 6, 20222 min read
USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances
USFDA finalized and released four Guidelines yesterday (05 October 2022), in accordance with the time frames set forth in the Generic...
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Sharan Murugan
Aug 7, 20221 min read
USFDA's New WebPage: For Complex Generics
Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...
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Sharan Murugan
Apr 17, 20221 min read
FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products
On April 13, 2022, FDA published new draft guidance for the industry entitled “Considerations for Waiver Requests for pH Adjusters in...
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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...
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Sharan Murugan
Sep 23, 20211 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...
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