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FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Allay Pharmaceuticals and Ignacio J. Rodriguez.

Medical Devices

FDA Monitoring Covid Ventilator Splitters

FDA says it is monitoring clinical experience with ventilator splitters in situations in which no alternatives for invasive ventilatory support are av...

Human Drugs

Broaden Cancer Trial Eligibility: Advocates

Two cancer advocacy groups publish recommendations on broadening eligibility criteria for cancer trials to make trials more accessible to patients.

Human Drugs

Adulterated ShangRao Hand Sanitizer

FDA warns Chinas ShangRao Chunyu Technology Co. that its hand sanitizer that was detained at the U.S. border did not contain the labeled percentage of...

Human Drugs

More Evidence of Political Meddling in Coronavirus: Subcommittee

The House Select Subcommittee on the Coronavirus Crisis says it has found additional evidence of the Trump administrations political interference in t...

Animal Drugs

FDA Lists Veterinary Regenerative Medicine Studies

FDA publishes a Web page with listings of clinical field studies of animal cells, tissues, and cell- and tissue-based products.

Medical Devices

Hold 3rd-Party Device Servicers Accountable: MITA

The Medical Imaging and Technology Alliance says FDA should exercise greater oversight over third-party medical device servicing organizations.

Human Drugs

Corrigan-Curay on Detail on CDER Directors Office

CDER Office of Medical Policy director Jacqueline Corrigan-Curay begins a detail to the Office of the Center Director as deputy director for operation...

Human Drugs

Appeals Court to Re-Hear Teva Skinny Label Case

The U.S. Court of Appeals for the Federal Circuit says it will reconsider a 2020 decision to uphold a jury award of $235 million to GlaxoSmithKline ov...

Report Analyzes False Claims Act Enforcement Developments

A Hogan Lovells False Claims Act enforcement report says the new Biden administration and a priority on coronavirus cases will lead to significant ris...