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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...

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...

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...

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...

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)...

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...

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 "...