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Guidance on ANDA Cover Letter Attachments

[ Price : $8.95]

FDA posts a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.

Guide on Nonclinical Immunotoxic Evaluations

[ Price : $8.95]

FDA posts a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.

Therapeutic Protein Drug-Drug Interactions Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Drug-Drug Interaction (DDI) Assessment for Therapeutic Prot...

Guide on Bladder Pain Syndrome Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance entitled Interstitial Cystitis/Bladder Pain Syndrome: Establ...

FDA Lifts Hold on Multiple Myeloma Drug

[ Price : $8.95]

FDA removes a two-month-long partial clinical hold on a Molecular Templates Phase 1 multiple myeloma study of MT-0169 that was bas...

Durbin Urges FDA to Act More on Cancer Drug Shortage

[ Price : $8.95]

Senator Dick Durbin (D-IL) urges FDA to do more to improve supply shortages of critical cancer drugs.

Kyverna Gets Fast Track for Lupus Nephritis Drug

[ Price : $8.95]

FDA grants Kyverna Therapeutics a fast track designation for KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy for tr...

Therapeutic Protein Drug Interaction Assessment Guide

[ Price : $8.95]

FDA posts a final guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.

Guidance on Device Pre-Submission Meetings

[ Price : $8.95]

FDA releases a final guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program...

Guide on Nonclinical Immunotoxic Evaluations

[ Price : $8.95]

FDA releases a final guidance entitled Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.