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Biopharmaceutics Classification Biowaivers Guidance

[ Price : $8.95]

FDA publishes an International Council for Harmonization guidance on the Biopharmaceutics Classification System-based biowaivers.

FDA Withdrawing 12 No-Longer Marketed ANDAs

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency in writing tha...

Qualified Infectious Disease Product Designation Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Qualified Infectious Disease Product Designation Questions...

Guide on Developing Covid Drugs/Biologics

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Trea...

Rocket Pauses Phase 1 Danon Disease Trial

[ Price : $8.95]

Rocket Pharmaceuticals says FDA asked it to pause patient dosing and modify the protocol for its Phase 1 trial of RP-A501 to treat...

Company Selling Unapproved Covid Test: FDA

[ Price : $8.95]

FDA says Anytime Covid Test is marketing and distributing unapproved, adulterated, and misbranded Covid-19 tests for home use.

Seyfert-Margolis Joins Penrose Scientific Advisory Board

[ Price : $8.95]

Penrose TherapeuTx appoints former FDAer Vicki Seyfert-Margolis to its scientific advisory board.

Novo Nordisk Recalls Insulin Product Samples

[ Price : $8.95]

Novo Nordisk recalls 1,468 product samples due to improper storage.

ICH Elemental Impurities Guideline Revisions

[ Price : $8.95]

FDA releases for public comment proposed revisions to an International Council for Harmonization guideline on elemental impurities...

Breakthrough Status for Avenda Prostate Cancer AI Device

[ Price : $8.95]

FDA grants breakthrough device designation to Avenda Healths prostate cancer artificial intelligence-enabled focal therapy system....