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Sharan Murugan
Dec 6, 20221 min read
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
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Sharan Murugan
Dec 2, 20221 min read
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
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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...
114 views0 comments
Sharan Murugan
Nov 19, 20221 min read
USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...
32 views0 comments
Sharan Murugan
Nov 12, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
34 views0 comments
Sharan Murugan
Nov 12, 20222 min read
USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”
According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the...
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Sharan Murugan
Nov 8, 20221 min read
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
Earlier today (November 8, 2022) USFDAs Center for Drug Evaluation and Research, Office of Generic Drugs released a Draft guideline on...
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Sharan Murugan
Nov 4, 20221 min read
USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology,...
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Sharan Murugan
Nov 1, 20221 min read
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
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Sharan Murugan
Nov 1, 20221 min read
USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Earlier today (1-November-2022) the USFDA finalized and released "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based...
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Sharan Murugan
Nov 1, 20221 min read
USFDA's Notice: CMC Development & Readiness Pilot Program
Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...
21 views0 comments
Sharan Murugan
Oct 27, 20221 min read
USFDA Guidance: Developing & Responding to Deficiencies - Least Burdensome Provisions
Earlier today (28-October-2022) the USFDA released final guidance on "Developing and Responding to Deficiencies in Accordance with the...
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Sharan Murugan
Oct 23, 20221 min read
USFDA MD Guidance: Breakthrough Devices Program - Reducing Disparities in Health & Health Care
Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...
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Sharan Murugan
Oct 22, 20221 min read
USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections
The USFDA recently revised two compliance programs, which will go into effect from, October 17, 2022: Preapproval Inspections Drug...
18 views0 comments
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...
47 views0 comments
Sharan Murugan
Oct 17, 20221 min read
USFDA Guidance: Multiple Guidances related to Oncology
USFDA's Oncology Center of Excellence released multiple guidances related to Oncology earlier today (17-Oct-2022). Guidance on:...
26 views0 comments
Sharan Murugan
Oct 17, 20221 min read
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
Center for Drug Evaluation and Research (CDER) finalized and released updated guidance on "ANDA Submissions – Prior Approval Supplements...
220 views0 comments
Sharan Murugan
Oct 17, 20221 min read
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
This guidance was finalized and released by the Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and...
56 views0 comments
Sharan Murugan
Oct 7, 20221 min read
USFDA MD Guidance: Postmarket Surveillance & Procedures for Handling Post-Approval Studies
USFDA's Center for Devices and Radiological Health released two updated, finalized guidelines yesterday and earlier today...
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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...
81 views0 comments