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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

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.

Biologics

HTLV-I/II Serological Test Guidance

FDA issues a guidance with recommendations for blood collection establishments on using serological tests to reduce the risk of transmission of human ...

Federal Register

OTC Panel to Discuss Food Handler Antiseptics

Federal Register notice: FDA announces a 3/11 Nonprescription Drugs Advisory Committee meeting on food handler antiseptic drug products.

Human Drugs

Draft Guide on Sanfilippo Syndrome Drugs

Federal Register notice: FDA makes available a draft guidance entitled Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Trea...

Human Drugs

Companies Pay for Some Panel Testimony: Study

A Medscape commentary column recommends that FDA prevent drug companies from covering expenses for any public individuals who testify at an advisory c...

Federal Register

Public Meeting on Drug eSubmissions, Data Standards

Federal Register notice: FDA announces a 4/22 public meeting on Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.