FDA Commissioner Dr. Scott Gottlieb said on Tuesday he hasn't talked to the GOP senators working on an ACA replacement about what will happen if millions of Americans lose access to treatment.
On Tuesday the White House will defend proposed cuts to the FDA budget that physicians fear will mean lax oversight of drug approval.
The FDA's request marks the first time the agency has tried to get an opioid pain medication off the market because of the public health consequences of abuse.
The FDA's request marks one of the first times the agency has tried to get an opioid pain medication off the market because of the public health consequences of abuse.
The U.S. Food & Drug Administration awarded Athersys' clinical program for stroke fast track designation, an expedited drug development and review program for new drugs or biologics to treat serious or life-threatening conditions.
FDA Commissioner Scott Gottlieb has suggested that limiting painkiller prescriptions could be a key tool to battle the opioid addiction crisis gripping the nation. Addiction experts say doctors should have the final say on when and how long the drugs are used.
A House subcommittee added an amendment taking aim at rising drug prices to the FDA fee schedule reauthorization bill, but some observers say it will do little to curb abusive pricing of off-patent branded drugs.
Increasing competition, reforming outdated laws, improving data infrastructure and letting market forces work are key to lowering drug costs, according to a new paper.
Sanofi's commitment to limit prices to the rise in the National Health Expenditure Data Accounts—estimated to be 5.6% annually from 2016 to 2025—is not enough, healthcare experts said.
The Senate's Committee on Health, Education, Labor & Pensions late last week voted 21-2 to approve a bipartisan bill that reauthorized the FDA's ability to collect fees from companies that make prescription brand drugs, medical devices, generic drugs and biosimilars.
The act, which calls for more than $400 million in additional user fees to be collected from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, looks to expedite new drug approvals. The committee added amendments aimed at increasing competition.
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...