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Temporary FDA director replaces Scott Gottlieb

WIth a temporary replacement named to the top seat of the Food and Drug Administration today, pharmaceutical industry leaders expressed relief, while others puzzled at the unexpected departure.

FDA Commissioner Scott Gottlieb steps down; stakeholders concerned about future

Food and Drug Administration (FDA) commissioner Scott Gottlieb announced his planned resignation last week and will step down next month, leaving stakeholders concerned about the future.

Israeli device for treating Alzheimer's moves slowly through FDA-approval process for use in U.S.

An Israeli company is still working to get a medical device it says treats and potentially cures Alzheimer’s disease to be approved for use in the United States.

Heartland Institute's Hudgins says U.S. could learn from Japanese drug-approval model

Heartland Institute's Hudgins says U.S. could learn from Japanese drug-approval model

U.S. FOOD AND DRUG ADMINISTRATION: The agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

U.S. FOOD AND DRUG ADMINISTRATION: FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics.

U.S. FOOD AND DRUG ADMINISTRATION: FDA’s modern approach to advanced pharmaceutical manufacturing

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing

FDA Reporter