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Human Drugs

Products Association Sues FDA Over NAC

The Natural Products Association says it is suing to force FDA to stop regulating N-acetyl-L-cysteine.

Medical Devices

No FDA OK in Effect for Induction Therapies Product

FDA warns Induction Therapies about marketing its Collagen P.I.N. microneedling product without agency approval.

Human Drugs

Califf Nomination Heads to Senate HELP Hearing

The Senate Health, Education, Labor & Pensions Committee announces a 12/14 hearing on the nomination of Robert Califf to be the next FDA commissioner.

Human Drugs

FDA Inspections Will Adapt to New Strategies: Attorneys

A Kleinfeld, Kaplan & Becker online post predicts that the prolonged Covid-19 pandemic will likely see the agency continue to adapt and utilize new st...

Human Drugs

2 Influencers Call for Using More RWD in Trials

Two MedHealth influencers say the health community must find ways to expand the use of real-world data in clinical trials.

Biologics

CBER Cell/Gene Therapy Office Swamped: Director

CBER Office of Tissues and Advanced Therapies director Wilson Bryan says the office is swamped with new product submissions to the extent that it is c...

Hahn Leading Harbinger Health Testing Startup

Former FDA commissioner Stephen Hahn is named CEO of Harbinger Health.

Human Drugs

FDA Reviewers Doubt Reata Kidney Drugs Effectiveness

Ahead of a 12/8 FDA advisory committee meeting, agency reviewers cast doubt on the effectiveness of Reata Pharmaceuticals bardoxolone to slow the loss...

Biologics

Theratechnologies sBLA for HIV Drug Administration

Theratechnologies files a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous push form of administration for treating HIV-1 in combina...

Federal Register

Mammography Panel Seeks Nonvoting Reps

Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH...