North Carolina House introduces stem cell therapy bill
A bill proposing the right to try adult stem cell treatments was introduced in the North Carolina House on April 22.
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Rising number of FDA advisory positions left unfilled
The number of vacancies on U.S. Food and Drug Administration advisory committees ticked upward during the final months of 2018, according to the agency’s most recent numbers.
Corey Polen battles for right to receive ALS medication
Corey Polen was a healthy 40-year-old man enjoying his life with his wife and three children. In October of 2015 that all changed when he started feeling spurts of weakness, not thinking too much about it until it began to progress rapidly with no answers.
FDA could be prohibiting terminal patients from life-saving treatments and medication
The world of pharmaceuticals and biotechnology is ever-growing and changing, but seemingly only behind closed doors.
Research group calls for a moratorium on opioid production and asks for FDA's Woodcock to step down
Health research group Public Citizen's founder, Sidney Wolfe, believes a moratorium on opioid production is necessary because new opioids and reformulations of opioids have more known risks than benefits.
Fiscal year 2019 FDA medical device fees released
Fee rates and payment instructions for companies submitting new medical device applications to the federal Food and Drug Administration have been released for fiscal year 2019, which began on Oct. 1, 2018.
Measles cases in U.S. hit 465 so far this year, CDC reports
The number of U.S. measles cases confirmed this year as of April 4 reached 465, the second-highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.
FDA OK'd 272 drugs in March
The U.S. Food and Drug Administration approved 272 drug products in March, according to a list the agency published on Thursday.
FDA approves new drug for multiple sclerosis
People who suffer from multiple sclerosis (MS) have a new hope of slowing the progression of their disease with the U.S. Food and Drug Administation’s (FDA) approval of a new drug.
FDA studying ways to improve medical device safety
Silicone breast implants, metal rods to stabilize broken bones, heart valves made from the tissues of pigs and cows—modern medical technology is continually developing devices to implant in human bodies to improve health, quality of life, or appearance.
FDA Update: Which drugs are in short supply?
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
FDA seeks to reform clinical trials
SILVER SPRING, Md. -- The Food and Drug Administration (FDA) wants to overhaul the current clinical trial process by giving patients, doctors and researchers clearer access to clinical trial information, according to a new FDA statement released by former FDA Commissioner Dr. Scott Gottleib, current FDA director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, and current chief of staff to the FDA commissioner, Lauren Silvis.
Medical device makers likely to benefit from ‘similar product’ expedited approval process in 2019
Keeping pace with technology that seems to develop at the speed of light and getting medical treatments to the people who most need them as quickly as possible while still maintaining top standards and keeping patients safe is tricky for the U.S. Food and Drug Administration, but that is its job.
Seminar scheduled for learning how to handle FDA recalls
No company wants its product recalled by the U.S. Food and Drug Administration, but it can happen despite the most careful product planning.
Feedback flowing in to FDA following draft policy document publication
Feedback is continuing to flow in the FDA following the publication of a draft policy document on the future of combination products.
Administration proposes Medicare patients get coverage for innovative devices
The current administration’s proposed budget for 2020 includes allowing Medicare patients to benefit from more and longer access to “breakthrough” medical devices, and the industry could not be happier.
FDA regulations easier for devices than drugs
The U.S. Food and Drug Administration is the agency that ultimately decides upon the safety of medical applications, both pharmaceuticals and devices, and approves their use by providers to the public.
Natural Cycles contraception app gets final FDA clearance
This month the U.S. Food and Drug Administration took the final steps in clearing the first family-planning app approved for use in the U.S.
21st Century Cures Act: Interoperability, information blocking and the ONC Health IT Certification Program
While today's technology offers us a world of information that previous generations never even dreamed of being so accessible, important medical and health records remain time-consuming and difficult to obtain.
Influenza activity down slightly but remains high, CDC says
Reports of influenza cases inched downward during the week ending March 9, but they remain relatively high due in part to the spread of the H3N2 virus, the Centers for Disease Control and Prevention reported.