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Sharan Murugan
Mar 31, 20231 min read
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...
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Sharan Murugan
Mar 30, 20231 min read
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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Sharan Murugan
Mar 30, 20232 min read
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...
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Sharan Murugan
Mar 28, 20231 min read
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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Sharan Murugan
Mar 27, 20232 min read
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...
23 views0 comments
Sharan Murugan
Mar 24, 20231 min read
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...
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Sharan Murugan
Mar 24, 20231 min read
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...
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Sharan Murugan
Mar 17, 20231 min read
USFDA Guidance: Pharmacogenomic Data Submissions
Earlier today (16 March 2023) the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Center for Biologics...
18 views0 comments
Sharan Murugan
Mar 16, 20231 min read
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...
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Sharan Murugan
Mar 1, 20231 min read
USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens
Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...
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Sharan Murugan
Mar 1, 20231 min read
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...
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Sharan Murugan
Feb 21, 20232 min read
USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices
The Center for Devices and Radiological Health released multiple guidances earlier today (21-February-2023), related to "Laser Products,...
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Sharan Murugan
Feb 1, 20231 min read
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...
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Sharan Murugan
Jan 31, 20231 min read
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...
35 views0 comments
Sharan Murugan
Jan 17, 20231 min read
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
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![USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_auto/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg)
Sharan Murugan
Jan 16, 20231 min read
USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions
Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
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Sharan Murugan
Jan 4, 20231 min read
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...
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Sharan Murugan
Dec 27, 20221 min read
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...
121 views0 comments
Sharan Murugan
Dec 15, 20221 min read
USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter
Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...
48 views0 comments
Sharan Murugan
Dec 7, 20221 min read
USFDA Guidance: Homeopathic Drugs Products
Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic...
31 views0 comments