A Senate committee last week voted to send the nomination of Dr. Scott Gottlieb as head of the Food and Drug Administration to the full Senate. Members of the Senate Health, Education, Labor and Pensions Committee voted 14-9 to advance Gottlieb's nomination as FDA...
A Senate committee voted 14-9 to send Dr. Scott Gottlieb's nomination as head of the U.S. Food and Drug Administration to the full Senate.
The tentative deal to reauthorize the FDA's ability to collect user fees could be a boon to many healthcare companies by providing more certainty and efficiency in the product approval process, healthcare and legal experts said.
Pfizer is one of several saline manufacturers that received subpoenas seeking documents regarding manufacturing, pricing and communication with competitors.
St. Jude Medical, which is now part of Abbott Laboratories, failed to appropriately correct issues found in some of its cardiovascular devices, according to the U.S. Food and Drug Administration.
Dr. Scott Gottlieb is by far the most conflicted person nominated to run the 111-year-old Food and Drug Administration. If the Office of Government Ethics was doing its job, it wouldn't let him near the commissioner's chair for at least a year.
A bipartisan pair of congressmen on Thursday proposed a bill in the U.S. House of Representatives to try to prevent drugmakers from blocking generic and biosimilar competitors.
Dr. Scott Gottlieb Wednesday said he believes the federal government can speed up the approval of new drugs and devices while maintaining standards and leaving decisionmaking in the hands of clinicians.
The U.S. Senate Health, Education, Labor & Pensions Committee will evaluate the future of the fees the Food and Drug Administration levies on medical products during a hearing Tuesday.
Experts focused on finding ways to curb the number of overdoses in the U.S. say there's one very important person missing from President Donald Trump's commission—any representative from the federal agency regulating prescription drugs.
The Food and Drug Administration is warning physicians that patients implanted with the nation's only approved dissolvable heart stent may be having more cardiac issues than those with a traditional stent.
More than 3,700 women have filed lawsuits against the company in the U.S., alleging harm from its permanent sterilization device Essure.