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Sharan Murugan
Feb 6, 20221 min read
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...
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Sharan Murugan
Dec 11, 20211 min read
USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions
On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...
216 views0 comments
Sharan Murugan
Dec 11, 20212 min read
Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making
Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...
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Sharan Murugan
Nov 30, 20211 min read
Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA
Yesterday, the USFDA issued draft guidance for the industry titled Real-World Data: Assessing Registries to Support Regulatory...
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Sharan Murugan
Nov 7, 20211 min read
Draft Guidance for Device Software in Premarket Submissions - USFDA
This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket...
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Sharan Murugan
Nov 7, 20211 min read
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
Drug-Medical Device Combination Product (DMDCP): Primary mode of action is based on pharmacological, immunological or metabolic action...
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Sharan Murugan
Nov 7, 20211 min read
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when...
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Sharan Murugan
Oct 12, 20211 min read
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...
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Sharan Murugan
Sep 29, 20212 min read
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...
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Sharan Murugan
Aug 30, 20211 min read
Draft MD Guidance on Performance Criteria for Safety and Performance Based Pathway - USFDA
On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...
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Sharan Murugan
Aug 30, 20211 min read
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...
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Sharan Murugan
Aug 21, 20211 min read
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...
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Sharan Murugan
Aug 8, 20211 min read
Guidance’s on GMP for Investigational Products & for R&D facilities -WHO
World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...
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Sharan Murugan
Jul 28, 20211 min read
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...
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Sharan Murugan
Jul 5, 20211 min read
Draft guidance for Transdermal Adhesion Systems– US FDA
This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...
11 views0 comments
Sharan Murugan
Jun 26, 20211 min read
Draft Guidance on Remanufacturing of Medical Devices- USA-FDA
Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...
2 views0 comments
Sharan Murugan
Jun 26, 20211 min read
Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...
115 views0 comments
Sharan Murugan
Jun 19, 20211 min read
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...
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Sharan Murugan
Jun 11, 20211 min read
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
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