As policymakers and the drug and device industry look for new ways to bring treatments for life-threatening conditions to the market sooner, providers are concerned that expedited approvals could compromise patient care.
With its new Software Precertification Pilot Program, the FDA hopes to find a way to reduce the now significant burden on companies to get their software approved.
Invacare is finally free to build as many wheelchairs as it pleases. The U.S. Food and Drug Administration has given the company permission to ramp up manufacturing at its Elyria, Ohio, plant.
The Food and Drug Administration in June took steps to increase competition by posting a list of branded drugs that are not protected by patent and are not facing looming generic drug rivals. The agency will fast-track its review of generic drug applications.
The Food and Drug Administration took steps Tuesday to try to curb drug prices by increasing competition in the pharmaceutical market. The agency published a list of off-patent branded drugs without approved generics and will expedite review of generic drugs that have few competitors.
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.
Increasing competition, reforming outdated laws, improving data infrastructure and letting market forces work are key to lowering drug costs, according to a new paper.