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USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
A final industry guidance, "Clinical Drug Interactions Studies with Combined Oral Contraceptives", was released by the United States Food...
Sharan Murugan
Jun 8, 20231 min read
23 views
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USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...
Sharan Murugan
Jun 6, 20231 min read
14 views
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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...
Sharan Murugan
Jun 5, 20231 min read
121 views
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USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
Last week (02 June 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research, Center for Drug...
Sharan Murugan
Jun 4, 20232 min read
32 views
0 comments
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...
Sharan Murugan
Jun 4, 20231 min read
23 views
0 comments
USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Yesterday (31 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) proposed a new...
Sharan Murugan
Jun 1, 20231 min read
30 views
0 comments
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
Today (26 May 2023) the United States Food & Drug Administration released multiple guidances related to both drugs/biologics and medical...
Sharan Murugan
May 25, 20232 min read
12 views
0 comments
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...
Sharan Murugan
May 25, 20232 min read
152 views
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USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...
Sharan Murugan
May 18, 20232 min read
24 views
0 comments
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...
Sharan Murugan
May 13, 20231 min read
52 views
0 comments
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022
This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 4, 20231 min read
40 views
0 comments
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 4, 20231 min read
65 views
0 comments
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...
Sharan Murugan
May 2, 20232 min read
17 views
0 comments
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
Sharan Murugan
Apr 29, 20232 min read
22 views
0 comments
USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"
Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...
Sharan Murugan
Apr 23, 20231 min read
14 views
0 comments
USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs
Today (12 April 2023) USFDA's Center for Drug Evaluation and Research released two draft guidances on"Assessing Adhesion With Transdermal...
Sharan Murugan
Apr 12, 20231 min read
56 views
0 comments
USFDA Guidance: Format and Content for OTC Monograph Order Requests
Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...
Sharan Murugan
Apr 12, 20231 min read
72 views
0 comments
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...
Sharan Murugan
Apr 11, 20231 min read
32 views
0 comments
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...
Sharan Murugan
Apr 5, 20231 min read
50 views
0 comments
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...
Sharan Murugan
Apr 5, 20232 min read
63 views
0 comments