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Pfizer Gets Traditional Approval for Tivdak

[ Price : $8.95]

FDA gives Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or met...

Info Collection on FDA Recall Regs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....

Listening Session on Advisory Committee Revamp

[ Price : $8.95]

Federal Register notice: FDA announces a 6/13 virtual public meeting entitled Listening Session: Optimizing FDAs Use of and Proces...

QS Violations in Unapproved Spectrum Devices

[ Price : $8.95]

FDA warns the UKs Spectrum Medical about QS violations in its production of unapproved perfusion system devices.

VITEK 2 Antimicrobial Test Cards Recalled

[ Price : $8.95]

BioMrieux recalls its VITEK 2 AST antimicrobial sensitivity testing cards due to a higher concentration of ceftriaxone antibiotic ...

Draft Guide on Cell/Gene Therapy Considerations

[ Price : $8.95]

Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Mat...

Guide on Composition and Ingredient Statements

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and AN...

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FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell a...