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Help Industry with Bad Labs: Post

[ Price : $8.95]

A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA should help industry learn how to avoid labs that...

QS, MDR Issues Seen in Exactech Inspection

[ Price : $8.95]

FDA warns Gainesville, FL-based Exactech about Quality System and Medical Device Report violations in its manufacturing of orthope...

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FDA publishes a draft guidance with recommendations for NDA and ANDA applicants for nonprescription drugs to document minor labeli...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FDA publishes a draft guidance proposing select updates to its existing premarket cybersecurity guidance.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

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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

[ Price : $8.95]

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