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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...
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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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