Masks arrive from ‘dubious’ sources, bearing false FDA certificates: report
By
Alicia Lasek
Jul 21, 2020
In a rush to meet demand for face masks and respirators, some manufacturers have turned out poor quality products while claiming federal approval, according to a new report.
‘Most dangerous’ pandemic months ahead, former FDA leader tells providers
By
Danielle Brown
Nov 18, 2020
A former leader of the Food and Drug Administration is warning long-term care providers to stay vigilant and proactive as they head into the “seventh inning” of the coronavirus public health crisis.
Accessory for swimming approved for cochlear implants
Apr 22, 2014
The Food and Drug Administration has approved the Aqua+ accessory, a waterproof, behind-the-ear product for cochlear implant recipients. The accessory allows Cochlear™ Nucleus® 5 and Nucleus 6 Implant...
Vaccine to protect seniors from RSV ready for FDA review, drugmaker says
By
Alicia Lasek (f3)
Jun 13, 2022
A vaccine to help prevent a leading cause of pneumonia in the elderly has been found effective in late-stage clinical trials.
Infection fighters: FDA, APIC put spotlight on nurses, drug development in fight against drug resistance
By
Kimberly Marselas
Jun 13, 2018
The Food and Drug Administration on Tuesday released draft guidelines that should make it easier to develop new antibiotics and antifungal drugs, one facet of a multi-pronged approach to limiting antimicrobial...
FDA to withdraw certain drug-related guidances with end of PHE
By
Alicia Lasek
Mar 14, 2023
The Food and Drug Administration has issued a notice detailing which COVID-19-related guidances will expire when the public health emergency ends as scheduled on May 11, and which guidances will remain...
FDA advisers endorse bivalent vaccine for all COVID mRNA shots
By
Alicia Lasek
Jan 27, 2023
A panel of experts on Thursday agreed that the bivalent COVID-19 vaccines should be used as both initial and booster shots, phasing out the original vaccines.
FDA OKs new insulin biosimilar for type 2 diabetes
By
Alicia Lasek
Jul 30, 2021
Semglee is a safe and more cost-effective alternative to the drug Lantus (insulin glargine), the agency announced Wednesday. Semglee does not need a prescriber’s input to be substituted at the pharmacy.
FDA approves first biosimilar treatment
By
Elizabeth Newman
Apr 06, 2015
The Food and Drug Administration approved its first biosimilar product in March, opening the door for more costly drug alternatives.
Lawmakers push FDA to take swift action on OTC hearing aids
By
Diane Eastabrook
Apr 12, 2022
A bipartisan team has introduced a bill that orders the FDA to stop dragging its feet and issue a final rule making over-the-counter hearing aids available to consumers.