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USFDA Guidance: Controlled Correspondence Related to Generic Drug Development

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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USFDA Guidance: Assessing User Fees Under the GDUFA of 2022

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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USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions

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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USFDA Update: In-Person, Face-to-Face ANDA Program Meetings

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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Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System

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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Sharan Murugan

Dec 27, 2022
1 min

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Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

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USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug

Sharan Murugan

Dec 2, 2022
1 min

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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USFDA Guidances: Topical Generic Drug Products - ANDAs

Sharan Murugan

Oct 22, 2022
2 min

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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USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances

Sharan Murugan

Oct 6, 2022
2 min

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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USFDA's New WebPage: For Complex Generics

Sharan Murugan

Aug 7, 2022
1 min

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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FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products

Sharan Murugan

Apr 17, 2022
1 min

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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USFDA Guidance update on Generic Drug Application Submissions, Labeling, and Review

Sharan Murugan

Jan 27, 2022
1 min

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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USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs

Sharan Murugan

Sep 23, 2021
1 min

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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