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Guide on Pediatric Study Plans

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Pediatric Study Plans: Content of and Process for Submittin...

Available Guidances Related to Covid-19

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Federal Register notice: FDA makes available guidance documents related to Covid19 public health emergency.

Comments Sought on Generics Fee Report

[ Price : $8.95]

Federal Register notice: FDA seeks comments on a report entitled Independent Evaluation of the GDUFA Resource Capacity Planning Ad...

Device Consensus Standards Database Updated

[ Price : $8.95]

FDA updates its recognized consensus standards database for medical devices.

Petition Seeks Ban on Music in DTC Ads

[ Price : $8.95]

A citizen petition asks FDA to ban music in direct-to-consumer television, radio and internet streamed advertisements because it d...

Content/Process Guide for Pediatric Study Plans

[ Price : $8.95]

FDA posts a final guidance on content and submission process for pediatric study plans.

Janssen sNDA for Spravato OKd for Major Depression

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FDA approves a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, t...

Submission Data Elements for Imported Vet Devices

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Federal Register proposed rule: FDA proposes to amend its regulations to require that certain data elements be submitted for veter...

FDA Withdraws Watson Generic Oxycodone/Ibuprofen

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Federal Register notice: FDA withdraws approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets,...

Genentech Triple Combo OKd for Melanoma

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FDA approves a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Z...