News from the FDA/CDC
News from the FDA/CDC
FDA cancels or postpones meetings amid COVID-19 concerns
Thus far, only a few Center for Drug Evaluation and Research events on the FDA's meeting webpage are listed as being canceled or postponed.
News from the FDA/CDC
FDA moves to expand coronavirus testing capacity; CDC clarifies testing criteria
Close to a million tests will be available by week’s end, predicted HHS Secretary Alex Azar
News from the FDA/CDC
FDA, FTC uniting to promote biosimilars
As part of their collaboration, the two agencies will be sponsoring a public workshop on March 9 to discuss...
News from the FDA/CDC
Prescription osteoarthritis relief gets OTC approval
The diclofenac sodium topical gel previously known as Voltaren Gel 1% will now be sold over the counter as Voltaren Arthritis Pain.
News from the FDA/CDC
ACIP updates recommendations for adult vaccines
The update includes changes regarding the administration of the influenza, HPV, hepatitis A and B, meningitis B, and PCV13 vaccines.
News from the FDA/CDC
CDC: Opioid prescribing and use rates down since 2010
News from the FDA/CDC
Washington state patient is first U.S. case of novel coronavirus
Feature
FDA advisers set high bar for new opioids
Two days of FDA discussion over three new opioids seeking U.S. approval highlighted the barriers these drugs now face.
News from the FDA/CDC
FDA committee rejects oxycodegol, new opioid designed for less abuse
A novel opioid molecule designed to have less abuse potential with slower CNS entry received a unanimous FDA committee turn down.
News from the FDA/CDC
FDA approves infliximab-axxq for numerous indications
This is the fourth biosimilar for this tumor necrosis factor inhibitor to receive FDA approval.
News from the FDA/CDC
FDA announces approval of fifth adalimumab biosimilar, Abrilada
Pfizer said that current plans are to launch the drug in the United States in 2023.