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Sharan Murugan
- Mar 20
- 2 min
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, 2023
- 1 min
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, 2023
- 1 min
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, 2023
- 1 min
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, 2023
- 1 min
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...
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