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Biologics

Health Experts Criticize FDA Covid-19 Vaccine Plan

Several health experts criticize FDAs recent guidance on minimum requirements for Covid-19 vaccines to obtain an emergency use authorization (EUA), sa...

Ex-CEO Gets 6 Months in Drug Marketing Case

The Western Virginia District Court sentences former Indivior CEO Shaun Thaxter to six months in federal prison for his role in causing the introducti...

Human Drugs

Warning Letter Sent to CBD Marketer Over Covid Claims

FDA sends For Our Vets (Mesa, AZ) a Warning Letter after reviewing its Web site and social media sites and determined that it offers CBD products for ...

Human Drugs

AuroLife Pharma Hit With Warning Letter

FDA sends New Delhi-based Aurobindo Pharma a Warning Letter citing its U.S subsidiary AuroLife Pharma based on an inspection at its oral solid manufac...

Federal Register

OTC Drug Time and Extent Info Collection Extension

Federal Register notice: FDA sends to OMB an information collection extension for Additional Criteria and Procedures for Classifying Over-the-Counter ...

Federal Register

Susceptibility Test Interpretive Criteria Updates

Federal Register notice: FDA makes available an annual compilation of updates to the agencys Susceptibility Test Interpretive Criteria Web page.

Biologics

FDA Greenlighting AZ Covid Vaccine Restart: Report

Reuters says FDA is ready to authorize AstraZeneca to resume its U.S. trial of a Covid-19 vaccine that has been on hold since 9/6 due to a trial parti...

Human Drugs

FDA Awards $1.1 Million Immunoinformatics Contract

FDA awards a $1.1 million contract to EpiVax and CUBRC to continue its work on evaluating generic peptide drugs and their impurities.

Human Drugs

Wholesale Distributor Verification Enforcement Off till 2023

FDA issues a compliance policy guidance delaying for three additional years enforcement of a provision for wholesale distributors to verify the produc...

FDA General

Azar Planning to Dump Hahn: Politico Report

Politico reports, based on anonymous sources, that HHS secretary Alex Azar is opening plotting to remove FDA commissioner Stephen Hahn from his post.