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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...
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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)...
284 views0 comments
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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 "...
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