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Federal Register notice: FDA makes available a draft guidance entitled Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Trea...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

Human Drugs

5 Observations in Lupin Andhra Inspection

FDA releases the FDA-483 with five observations from an inspection at the Lupin facility in Andhra, Pradesh, India.

Human Drugs

FDA Warns on Cesium Salts in Supplements

FDA warns consumers and healthcare professionals about the significant safety risks associated with using dietary supplements containing cesium salts.

Human Drugs

Dietary Supplement Violations Found in Marco Pharma Inspection

FDA warns Marco Pharma about CGMP and misbranding violations in its production of dietary supplements.

Human Drugs

CURE ID Undermines FDA Off-Label Speech Censorship: Column

Former Washington Legal Foundation chief counsel Richard Samp says the FDA launch of its CURE ID program to collect information on off-label prescribi...

Biologics

Ex-FDA Head Gottlieb Expects Virus Spreading in U.S.

Former FDA commissioner Scott Gottlieb expects the U.S. to see the coronavirus further spreading across the nation, and globally he expects it to get ...