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Minor Drug Labeling Change Reporting Guide

[ Price : $8.95]

FDA publishes a draft guidance with recommendations for NDA and ANDA applicants for nonprescription drugs to document minor labeli...

False or Misleading Senvelgo Claims: CVM

[ Price : $8.95]

CVM warns Boehringer Ingelheim Animal Health USA that promotional communications for its Senvelgo make false and misleading claims...

Cybersecurity Guidance Updates Proposed

[ Price : $8.95]

FDA publishes a draft guidance proposing select updates to its existing premarket cybersecurity guidance.

Digital Drug Marketing Workshop Themes

[ Price : $8.95]

A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital marketing identifies several ...

Most MDRs Hit Device Function Issues: Study

[ Price : $8.95]

FDA and Instem researchers say 92% of Medical Device Reports filed between 2011 and 2021 involved device issues rather than patien...

Adcetris Positive Lymphoma Data: Pfizer

[ Price : $8.95]

Pfizer plans to share with FDA favorable data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin)...

Lexicon Refiling NDA for Sotagliflozin in Diabetes

[ Price : $8.95]

Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets ...

Acadia Pharmaceuticals Nixes Schizophrenia Drug

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Acadia Pharmaceuticals stops developing pimavanserin for treating negative symptoms of schizophrenia based on disappointing top-li...

Alzheimers Drug Development Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment....

Biologic Adverse Event Reporting Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension on adverse experience reporting for licensed biologi...