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Listening Session on Improving Advisory Committees

[ Price : $8.95]

FDA plans a 6/13 listening session as part of its plan to revamp the use of advisory committees.

4-Year Enforcement Discretion for LDTs: Final Rule

[ Price : $8.95]

FDA offers a four-year enforcement discretion phase-out under a just-released final rule regulating laboratory-developed tests.

Human/Animal Materials in Cell/Gene Therapies Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell a...

SonarMed Recalls Airway Sensors

[ Price : $8.95]

SonarMed recalls its SonarMed Airway acoustic ventilator sensors due to a restricted inner diameter of the device resulting in dif...

Panel to Review Novo Nordisks Insulin Icodec

[ Price : $8.95]

Federal Register notice: FDA schedules a 5/24 Advisory Committee meeting to discuss Novo Nordisks BLA for insulin icodec.

Human Allogeneic Cell Safety Testing Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.

X4 Pharma Gains Xolremdi Approval

[ Price : $8.95]

FDA approves an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM synd...

Clinical Pharmacology Office Priorities Docket

[ Price : $8.95]

Federal Register notice: FDA creates a public docket entitled Promoting Effective Drug Development: Identifying Opportunities and ...

Draft Guide on Drug Composition Statements

[ Price : $8.95]

FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Sta...

Roivios Gets Breakthrough Status on Renal Assist

[ Price : $8.95]

FDA grants Roivios a breakthrough device designation for its JuxtaFlow Renal Assist Device and its use in safeguarding kidney func...