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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According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the...
Sharan Murugan
Nov 12, 20222 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...
Sharan Murugan
Nov 8, 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,...
Sharan Murugan
Nov 4, 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Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
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...
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...
Sharan Murugan
Nov 1, 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...
Sharan Murugan
Oct 27, 20221 min read
USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...
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Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...
Sharan Murugan
Oct 23, 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...
Sharan Murugan
Oct 22, 20221 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...
Sharan Murugan
Oct 22, 20222 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:...
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...
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...
Sharan Murugan
Oct 17, 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...
Sharan Murugan
Oct 7, 20221 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...
Sharan Murugan
Oct 6, 20222 min read
USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...
Sharan Murugan
Oct 6, 20221 min read
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
Earlier today (03 October 2022) USFDA released two finalized guidelines "Review of Drug Master Files in Advance of Certain ANDA...
Sharan Murugan
Oct 3, 20221 min read
USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
Earlier today (03-October-2022) USFDA's Center for Drug Evaluation and Research released an important CMC topic and final guidance "...
Sharan Murugan
Oct 3, 20221 min read
USFDA Guidance: Traditional Pre-Market Pathways for COVID Tests
Yesterday (27-September, 2022) USFDA released revised guidance on "Policy for Coronavirus Disease-2019 Tests During the Public Health...
Sharan Murugan
Sep 30, 20221 min read