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USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...
Sharan Murugan
Nov 19, 20232 min read
15 views
0 comments
USFDA Guidance: Real-Time Oncology Review (RTOR)
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) released guidance earlier this week (07 November 2023)...
Sharan Murugan
Nov 11, 20232 min read
25 views
0 comments
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
Sharan Murugan
Nov 6, 20232 min read
16 views
0 comments
USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers
Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical...
Sharan Murugan
Nov 5, 20231 min read
9 views
0 comments
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption
Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
Sharan Murugan
Nov 2, 20231 min read
20 views
0 comments
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...
Sharan Murugan
Oct 25, 20231 min read
23 views
0 comments
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...
Sharan Murugan
Oct 23, 20231 min read
18 views
0 comments
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food...
Sharan Murugan
Oct 23, 20232 min read
29 views
0 comments
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
Earlier today (17 October 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...
Sharan Murugan
Oct 17, 20232 min read
15 views
0 comments
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two guidances earlier this week ie, "Quality...
Sharan Murugan
Oct 14, 20231 min read
15 views
0 comments
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
Sharan Murugan
Oct 14, 20231 min read
11 views
0 comments
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders
A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and...
Sharan Murugan
Oct 6, 20231 min read
10 views
0 comments
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
The FDA revised section 5200.14 of the Manual of Policies and Procedures (MAPP), "Filing Reviews of Abbreviated New Drug Applications...
Sharan Murugan
Oct 4, 20232 min read
141 views
0 comments
USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
Earlier today (2 October 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics...
Sharan Murugan
Oct 2, 20232 min read
27 views
0 comments
USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
Sharan Murugan
Oct 2, 20232 min read
13 views
0 comments
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...
Sharan Murugan
Oct 2, 20231 min read
8 views
0 comments
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...
Sharan Murugan
Sep 21, 20232 min read
31 views
0 comments
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
Sharan Murugan
Sep 21, 20231 min read
27 views
0 comments
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
Sharan Murugan
Sep 20, 20232 min read
26 views
0 comments
USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program
Recently (14th September, 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
Sharan Murugan
Sep 19, 20232 min read
13 views
0 comments