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Drug Use-Related Software Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related...

English Doctor Attacks FDA/CDC Covid Vaccine Data

[ Price : $8.95]

A retired English doctor with almost 3 million YouTube subscribers scorns CDC and FDA data supporting mass vaccination of all Amer...

Drug Use-related Software Labeling Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software.

Substantial Evidence from 1 Trial Guidance

[ Price : $8.95]

FDA posts a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled ...

Petition Denied on Tacrolimus Bioequivalence

[ Price : $8.95]

FDA denies a 4/2020 Belcher Pharmaceuticals citizen petition that sought a requirement that drug makers of pre-12/2012-approved ta...

Vision Patient-reported Outcomes Workshop

[ Price : $8.95]

FDA announces a 9/29 virtual public workshop entitled Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires....

Novo Nordisk Gets FDA-483: Reports

[ Price : $8.95]

FDA reportedly issues Novo Nordisk a Form FDA-483 that cites GMP deficiencies at its Clayton, NC, manufacturing plant, which is a ...

Reverse Osmosis Dialysis Water Device Cleared

[ Price : $8.95]

FDA clears a B. Braun Medical 510(k) for its AQUAbase nX Reverse Osmosis System for providing high-quality water for dialysis pati...

Verona NDA for COPD Drug Accepted

[ Price : $8.95]

FDA accepts for review a Verona Pharma NDA for ensifentrine for the maintenance treatment of patients with chronic obstructive pul...

Draft Guide on Biosimilar Prescribing Info

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Prod...