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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Earlier on 21 October 2022, the USFDA released draft guidance "Select Updates for the Breakthrough Devices Program Guidance: Reducing...
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Sharan Murugan
Oct 22, 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...
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Sharan Murugan
Oct 22, 20222 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...
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Sharan Murugan
Oct 22, 20222 min read
UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products
The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...
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Sharan Murugan
Oct 17, 20221 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:...
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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...
213 views0 comments
Sharan Murugan
Oct 17, 20221 min read
EMA Guidance: Scientific Advice and Protocol Assistance
European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...
276 views0 comments
Sharan Murugan
Oct 17, 20221 min read
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme
The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...
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Sharan Murugan
Oct 13, 20221 min read
UK MHRA Guidance: How to get a Parallel Import Licence in UK
Earlier today Today (13 October 2022) Medicines and Healthcare products Regulatory Agency (MHRA) updated its Guidance on Medicines:...
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Sharan Murugan
Oct 13, 20221 min read
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...
197 views0 comments
Sharan Murugan
Oct 11, 20221 min read
MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI
The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active...
91 views0 comments
Sharan Murugan
Oct 9, 20221 min read
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued a Notification...
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Sharan Murugan
Oct 9, 20222 min read
Philippines FDA: Guidelines on the Unified Licensing Requirements
Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...
203 views0 comments
Sharan Murugan
Oct 7, 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...
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Sharan Murugan
Oct 6, 20222 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...
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Sharan Murugan
Oct 6, 20221 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...
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Sharan Murugan
Oct 3, 20221 min read
SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline
South African Health Products Regulatory Authority (SAHPRA) on 30 September 2022, released updated guidance on " Business As Usual (BAU)...
271 views0 comments
Sharan Murugan
Oct 3, 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...
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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 "...
92 views0 comments
Sharan Murugan
Sep 30, 20221 min read
Swissmedic Guidance: Medicinal Product Name HMV4
On 28 September 2022 Swissmedic updated and released their "Guidance document Medicinal product name HMV4 ". This guidance document...
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