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FDA General

2019 Ropes & Gray FDA Enforcement Review

Ropes & Gray attorneys review FDA enforcement action in a number of areas in 2019.

Human Drugs

Alarmingly High Antibiotic Scripts Not Infection Related

University researchers say nearly half of antibiotic fills for Medicaid patients do not involve treating an infection.

Human Drugs

5 Observations in Dr. Reddys FDA-483

FDA releases an FDA-483 with five observations from an inspection at a Dr. Reddys API manufacturing facility in Andhra Pradesh, India.

Medical Devices

FDA Clears Life Spines Plateau Ti

FDA clears a Life Spine 510(k) for its Steerable Plateau Ti Spinal System.

Human Drugs

Gottlieb Joins Illuminas Board of Directors

Former FDA commissioner Scott Gottlieb joins Illuminas board of directors.

Medical Devices

BD Surprised with 510(k) Request for Alaris Fixes

Becton Dickinson says FDA is requesting that modifications to the Alaris infusion pump will require a 510(k) filing.

Human Drugs

Gilead Lends Remdesivir to China for Coronavirus Trial

Gilead Sciences works with Chinese health authorities to begin a randomized, controlled study to determine whether the companys remdesivir can safely ...

Medical Devices

Former Walter Reed Employee Indicted on False Statements

A federal grand injury indicts a former Walter Reed National Military Medical Center employee on charges involving accepting financial benefits from a...

Human Drugs

Romark Seeks BE Restrictions on Alinia Generics

Romark Laboratories asks FDA to require several bioequivalence tests for any ANDA citing Romarks Alinia as the reference-listed product.

Medical Devices

FDA Reiterates Concern with Some Cardinal Surgical Gowns

FDA reposts a notice on the Cardinal Health recall of some of its Level 3 surgical gowns and PreSource Procedure Packs.