Articles Tagged With: FDA
-
Changes to Medication Abortion Could Result in Pharmacy Dispensing of the Drug
The easing of the risk evaluation and mitigation strategy restriction on mifepristone will make it easier for women to obtain the drug and could allow for pharmacy dispensing of the drug. Pharmacists should have a seat at the table in the conversation on dispensing prescription medication. -
Researchers Say It Is Time to Drop REMS Restriction on Mifepristone
The risk evaluation and mitigation strategy (REMS) restriction on mifepristone has been burdensome for providers and patients, researchers noted. The REMS restriction exacerbates the stigma around abortion care, which already disproportionately affects communities of color and young people. -
Reassuring Vaccine-Hesitant Healthcare Workers
A common misperception that has led to vaccine hesitancy in healthcare workers and the public is the COVID-19 vaccines were produced with undue haste, seemingly coming out of nowhere to respond to the pandemic. The extensive scientific work with many other viruses that enabled the rapid development of the pandemic vaccines often is left out of the equation. -
Vaccines Are Available, but the Search for COVID-19 Therapeutics Continues
Right after the FDA issued an emergency use authorization for one drug, feds pressed pause on distributing another. -
FDA Actions: Needle Hazards, Antibody Testing for Immunity
Due to “needle safety device failures” — some of which led to needlesticks — the FDA is recommending healthcare providers stop using certain syringes and needles manufactured by Guangdong Haiou Medical Apparatus Co., Ltd. (HAIOU). The FDA is recommending the action as it evaluates the products. So far, HAIOU has not initiated a voluntary recall. -
COVID-19 Vaccine Mandates for Healthcare Workers Have Begun
Houston Methodist Hospital is one of the first institutions in the nation to mandate COVID-19 vaccines for healthcare workers and other employees. Many see such mandates as the wave of the future, but others advise caution and patience to let staff make a willing choice about a controversial vaccine. -
Diversity in Clinical Trials Should Start with the Fundamentals
Diversity in clinical trials involves more than just including more minority participants, panelists said at a recent webinar. It is a commitment from leadership that addresses the diversity topic within every aspect of the clinical trial process. -
NIOSH, FDA Cracking Down on N95s
The National Institute for Occupational Safety and Health has revoked the public health emergency approval of an N95 respirator manufacturer after sample products failed filtering tests, according to a recent agency announcement.
-
FDA, CDC Back COVID-19 Vaccine for Adolescents
The Pfizer/BioNTech solution will be available for Americans age 12 to 15 years. -
FDA Makes Medication Abortion Available Via Telehealth
The FDA enabled reproductive health providers to prescribe mifepristone, the abortion medication, via telemedicine — at least through the duration of the pandemic. The FDA approved lifting the requirement of in-person dispensing of mifepristone, since the COVID-19 pandemic presents additional COVID-related risks to patients and healthcare personnel when patients visit a clinic solely to receive a prescription.